Director, External Manufacturing Quality, Cell Therapy
Bristol-Myers Squibb
Director, External Manufacturing Quality, Cell Therapy
Job Description
Ensures CMOs and CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles Support the BMS on-boarding CMO process including Technology Transfer, Quality Agreement generation, business process definition and Quality oversight framework Provide guidance and direction to the CMC DP team on quality compliance and GMP systems requirements for products manufactured on BMS's behalf Build a team to support Drug product release Act as Quality Liaison with CMOs used for the manufacture of BMS's products, intermediates and critical starting and raw materials Support the transition of CMO operations from clinical to commercial production including process validation, inspection readiness activities (GMP assessments and mock PLIs), and systems remediations Responsible for batch record review and final DP disposition prior to Japan RP release. Develop and manage team responsible for disposition of the drug product. Responsible for ensuring disposition of product is carried out within acceptable and agreed turnaround times. Provide out of hours coverage as required Responsible for review and approval of CMO investigations, CAPA, controlled documents Act as QA impact assessor and approver of CMO related changes Responsible for data auditing, reviewing and approval of protocol/reports in support of JNDA submissions Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits Assist in CMO GMP audits, as required Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition Partner with Technical Operations for run the business activities Serves as the BMS Quality Ops single point of contact and is responsible and accountable for the quality and compliance performance of the assigned CMOs Develop and monitor Key performance indicators(KPI) and develop proactive management of dashboards and KPIs Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner Work from CMO site as required Strong organizational skills, including ability to follow assignments through to completion Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projects Excellent verbal and written communication skills, and ability to work in an inter-disciplinary and cross-function team Detail-oriented with demonstrated applications in problem solving and solid decision-making abilities. With moderate oversight from Manager, think strategically and understand global impact of decisions Ability to manage and communicate at multiple levels of management Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas. A minimum of 12 years' experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable Quality Assurance experience will be considered Experience with QA oversight of Cell Therapy Durg product manufacturing, Cellular Therapeutics and/or gene-based products and biologics is preferred Knowledge of applicable PMDA regulations in the biotechnology industry Experience managing external suppliers and other supply chain issues and have experience of working under USFDA and EMA regulations Experience in building and growing an organization into a high performing team Excellent communication, troubleshooting, and problem-solving skills Strong team player, who can work independently to achieve objectives Ability to work effectively at a fast pace Excellent verbal and written communication skills Soft skills: negotiating and influencing
Key Responsibilities
- Ensure CMOs and CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits
- Support the BMS on-boarding CMO process including Technology Transfer, Quality Agreement generation, business process definition and Quality oversight framework
- Provide guidance and direction to the CMC DP team on quality compliance and GMP systems requirements for products manufactured on BMS's behalf
- Build a team to support Drug product release
- Act as Quality Liaison with CMOs used for the manufacture of BMS's products, intermediates and critical starting and raw materials
- Support the transition of CMO operations from clinical to commercial production including process validation, inspection readiness activities (GMP assessments and mock PLIs), and systems remediations
- Responsible for batch record review and final DP disposition prior to Japan RP release
- Develop and manage team responsible for disposition of the drug product
- Ensure disposition of product is carried out within acceptable and agreed turnaround times
- Provide out of hours coverage as required
- Responsible for review and approval of CMO investigations, CAPA, controlled documents
- Act as QA impact assessor and approver of CMO related changes
- Responsible for data auditing, reviewing and approval of protocol/reports in support of JNDA submissions
- Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits
- Assist in CMO GMP audits, as required
- Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO
- Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition
- Partner with Technical Operations for run the business activities
- Serve as the BMS Quality Ops single point of contact and be responsible and accountable for the quality and compliance performance of the assigned CMOs
- Develop and monitor Key performance indicators (KPI) and develop proactive management of dashboards and KPIs
- Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner
- Work from CMO site as required
Required Qualifications
- Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas
- A minimum of 12 years' experience in biopharmaceutical quality
- A minimum of 6 years of increasing management responsibility
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations
- Experience with QA oversight of Cell Therapy Drug product manufacturing, Cellular Therapeutics and/or gene-based products and biologics
- Knowledge of applicable PMDA regulations in the biotechnology industry
- Experience managing external suppliers and other supply chain issues
- Experience of working under USFDA and EMA regulations
- Experience in building and growing an organization into a high performing team
Skills Required
- Strong organizational skills, including ability to follow assignments through to completion
- Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projects
- Excellent verbal and written communication skills
- Ability to work in an inter-disciplinary and cross-function team
- Detail-oriented with demonstrated applications in problem solving and solid decision-making abilities
- Ability to think strategically and understand global impact of decisions with moderate oversight from Manager
- Ability to manage and communicate at multiple levels of management
- Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
- Excellent communication, troubleshooting, and problem-solving skills
- Strong team player, who can work independently to achieve objectives
- Ability to work effectively at a fast pace
- Soft skills: negotiating and influencing
Additional Requirements
- Work from CMO site as required
- Provide out of hours coverage as required
Locations
- Otemachi, Japan
Salary
Estimated Salary Rangemedium confidence
200,000 - 300,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong organizational skills, including ability to follow assignments through to completionintermediate
- Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Excellent verbal and written communication skillsintermediate
- Ability to work in an inter-disciplinary and cross-function teamintermediate
- Detail-oriented with demonstrated applications in problem solving and solid decision-making abilitiesintermediate
- Ability to think strategically and understand global impact of decisions with moderate oversight from Managerintermediate
- Ability to manage and communicate at multiple levels of managementintermediate
- Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definitionintermediate
- Excellent communication, troubleshooting, and problem-solving skillsintermediate
- Strong team player, who can work independently to achieve objectivesintermediate
- Ability to work effectively at a fast paceintermediate
- Soft skills: negotiating and influencingintermediate
Required Qualifications
- Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas (experience)
- A minimum of 12 years' experience in biopharmaceutical quality (experience)
- A minimum of 6 years of increasing management responsibility (experience)
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations (experience)
- Experience with QA oversight of Cell Therapy Drug product manufacturing, Cellular Therapeutics and/or gene-based products and biologics (experience)
- Knowledge of applicable PMDA regulations in the biotechnology industry (experience)
- Experience managing external suppliers and other supply chain issues (experience)
- Experience of working under USFDA and EMA regulations (experience)
- Experience in building and growing an organization into a high performing team (experience)
Responsibilities
- Ensure CMOs and CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits
- Support the BMS on-boarding CMO process including Technology Transfer, Quality Agreement generation, business process definition and Quality oversight framework
- Provide guidance and direction to the CMC DP team on quality compliance and GMP systems requirements for products manufactured on BMS's behalf
- Build a team to support Drug product release
- Act as Quality Liaison with CMOs used for the manufacture of BMS's products, intermediates and critical starting and raw materials
- Support the transition of CMO operations from clinical to commercial production including process validation, inspection readiness activities (GMP assessments and mock PLIs), and systems remediations
- Responsible for batch record review and final DP disposition prior to Japan RP release
- Develop and manage team responsible for disposition of the drug product
- Ensure disposition of product is carried out within acceptable and agreed turnaround times
- Provide out of hours coverage as required
- Responsible for review and approval of CMO investigations, CAPA, controlled documents
- Act as QA impact assessor and approver of CMO related changes
- Responsible for data auditing, reviewing and approval of protocol/reports in support of JNDA submissions
- Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits
- Assist in CMO GMP audits, as required
- Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO
- Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition
- Partner with Technical Operations for run the business activities
- Serve as the BMS Quality Ops single point of contact and be responsible and accountable for the quality and compliance performance of the assigned CMOs
- Develop and monitor Key performance indicators (KPI) and develop proactive management of dashboards and KPIs
- Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner
- Work from CMO site as required
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Answer 10 quick questions to check your fit for Director, External Manufacturing Quality, Cell Therapy @ Bristol-Myers Squibb.
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Director, External Manufacturing Quality, Cell Therapy
Bristol-Myers Squibb
Director, External Manufacturing Quality, Cell Therapy
Job Description
Ensures CMOs and CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles Support the BMS on-boarding CMO process including Technology Transfer, Quality Agreement generation, business process definition and Quality oversight framework Provide guidance and direction to the CMC DP team on quality compliance and GMP systems requirements for products manufactured on BMS's behalf Build a team to support Drug product release Act as Quality Liaison with CMOs used for the manufacture of BMS's products, intermediates and critical starting and raw materials Support the transition of CMO operations from clinical to commercial production including process validation, inspection readiness activities (GMP assessments and mock PLIs), and systems remediations Responsible for batch record review and final DP disposition prior to Japan RP release. Develop and manage team responsible for disposition of the drug product. Responsible for ensuring disposition of product is carried out within acceptable and agreed turnaround times. Provide out of hours coverage as required Responsible for review and approval of CMO investigations, CAPA, controlled documents Act as QA impact assessor and approver of CMO related changes Responsible for data auditing, reviewing and approval of protocol/reports in support of JNDA submissions Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits Assist in CMO GMP audits, as required Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition Partner with Technical Operations for run the business activities Serves as the BMS Quality Ops single point of contact and is responsible and accountable for the quality and compliance performance of the assigned CMOs Develop and monitor Key performance indicators(KPI) and develop proactive management of dashboards and KPIs Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner Work from CMO site as required Strong organizational skills, including ability to follow assignments through to completion Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projects Excellent verbal and written communication skills, and ability to work in an inter-disciplinary and cross-function team Detail-oriented with demonstrated applications in problem solving and solid decision-making abilities. With moderate oversight from Manager, think strategically and understand global impact of decisions Ability to manage and communicate at multiple levels of management Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas. A minimum of 12 years' experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable Quality Assurance experience will be considered Experience with QA oversight of Cell Therapy Durg product manufacturing, Cellular Therapeutics and/or gene-based products and biologics is preferred Knowledge of applicable PMDA regulations in the biotechnology industry Experience managing external suppliers and other supply chain issues and have experience of working under USFDA and EMA regulations Experience in building and growing an organization into a high performing team Excellent communication, troubleshooting, and problem-solving skills Strong team player, who can work independently to achieve objectives Ability to work effectively at a fast pace Excellent verbal and written communication skills Soft skills: negotiating and influencing
Key Responsibilities
- Ensure CMOs and CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits
- Support the BMS on-boarding CMO process including Technology Transfer, Quality Agreement generation, business process definition and Quality oversight framework
- Provide guidance and direction to the CMC DP team on quality compliance and GMP systems requirements for products manufactured on BMS's behalf
- Build a team to support Drug product release
- Act as Quality Liaison with CMOs used for the manufacture of BMS's products, intermediates and critical starting and raw materials
- Support the transition of CMO operations from clinical to commercial production including process validation, inspection readiness activities (GMP assessments and mock PLIs), and systems remediations
- Responsible for batch record review and final DP disposition prior to Japan RP release
- Develop and manage team responsible for disposition of the drug product
- Ensure disposition of product is carried out within acceptable and agreed turnaround times
- Provide out of hours coverage as required
- Responsible for review and approval of CMO investigations, CAPA, controlled documents
- Act as QA impact assessor and approver of CMO related changes
- Responsible for data auditing, reviewing and approval of protocol/reports in support of JNDA submissions
- Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits
- Assist in CMO GMP audits, as required
- Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO
- Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition
- Partner with Technical Operations for run the business activities
- Serve as the BMS Quality Ops single point of contact and be responsible and accountable for the quality and compliance performance of the assigned CMOs
- Develop and monitor Key performance indicators (KPI) and develop proactive management of dashboards and KPIs
- Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner
- Work from CMO site as required
Required Qualifications
- Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas
- A minimum of 12 years' experience in biopharmaceutical quality
- A minimum of 6 years of increasing management responsibility
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations
- Experience with QA oversight of Cell Therapy Drug product manufacturing, Cellular Therapeutics and/or gene-based products and biologics
- Knowledge of applicable PMDA regulations in the biotechnology industry
- Experience managing external suppliers and other supply chain issues
- Experience of working under USFDA and EMA regulations
- Experience in building and growing an organization into a high performing team
Skills Required
- Strong organizational skills, including ability to follow assignments through to completion
- Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projects
- Excellent verbal and written communication skills
- Ability to work in an inter-disciplinary and cross-function team
- Detail-oriented with demonstrated applications in problem solving and solid decision-making abilities
- Ability to think strategically and understand global impact of decisions with moderate oversight from Manager
- Ability to manage and communicate at multiple levels of management
- Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
- Excellent communication, troubleshooting, and problem-solving skills
- Strong team player, who can work independently to achieve objectives
- Ability to work effectively at a fast pace
- Soft skills: negotiating and influencing
Additional Requirements
- Work from CMO site as required
- Provide out of hours coverage as required
Locations
- Otemachi, Japan
Salary
Estimated Salary Rangemedium confidence
200,000 - 300,000 JPY / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong organizational skills, including ability to follow assignments through to completionintermediate
- Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Excellent verbal and written communication skillsintermediate
- Ability to work in an inter-disciplinary and cross-function teamintermediate
- Detail-oriented with demonstrated applications in problem solving and solid decision-making abilitiesintermediate
- Ability to think strategically and understand global impact of decisions with moderate oversight from Managerintermediate
- Ability to manage and communicate at multiple levels of managementintermediate
- Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definitionintermediate
- Excellent communication, troubleshooting, and problem-solving skillsintermediate
- Strong team player, who can work independently to achieve objectivesintermediate
- Ability to work effectively at a fast paceintermediate
- Soft skills: negotiating and influencingintermediate
Required Qualifications
- Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas (experience)
- A minimum of 12 years' experience in biopharmaceutical quality (experience)
- A minimum of 6 years of increasing management responsibility (experience)
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations (experience)
- Experience with QA oversight of Cell Therapy Drug product manufacturing, Cellular Therapeutics and/or gene-based products and biologics (experience)
- Knowledge of applicable PMDA regulations in the biotechnology industry (experience)
- Experience managing external suppliers and other supply chain issues (experience)
- Experience of working under USFDA and EMA regulations (experience)
- Experience in building and growing an organization into a high performing team (experience)
Responsibilities
- Ensure CMOs and CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits
- Support the BMS on-boarding CMO process including Technology Transfer, Quality Agreement generation, business process definition and Quality oversight framework
- Provide guidance and direction to the CMC DP team on quality compliance and GMP systems requirements for products manufactured on BMS's behalf
- Build a team to support Drug product release
- Act as Quality Liaison with CMOs used for the manufacture of BMS's products, intermediates and critical starting and raw materials
- Support the transition of CMO operations from clinical to commercial production including process validation, inspection readiness activities (GMP assessments and mock PLIs), and systems remediations
- Responsible for batch record review and final DP disposition prior to Japan RP release
- Develop and manage team responsible for disposition of the drug product
- Ensure disposition of product is carried out within acceptable and agreed turnaround times
- Provide out of hours coverage as required
- Responsible for review and approval of CMO investigations, CAPA, controlled documents
- Act as QA impact assessor and approver of CMO related changes
- Responsible for data auditing, reviewing and approval of protocol/reports in support of JNDA submissions
- Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits
- Assist in CMO GMP audits, as required
- Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO
- Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition
- Partner with Technical Operations for run the business activities
- Serve as the BMS Quality Ops single point of contact and be responsible and accountable for the quality and compliance performance of the assigned CMOs
- Develop and monitor Key performance indicators (KPI) and develop proactive management of dashboards and KPIs
- Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner
- Work from CMO site as required
Tags & Categories
Answer 10 quick questions to check your fit for Director, External Manufacturing Quality, Cell Therapy @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs