Senior Manager, CSCQ, Qualified Person
Bristol-Myers Squibb
Senior Manager, CSCQ, Qualified Person
Job Description
Support start-up activities for Clinical Supply Chain Quality Dublin, including but not limited to: Review and approval of QA/QP related procedures Support preparation and approval of training materials Support review and approval of Quality Agreements Ensure knowledge transfer from current release site Support Manufacturer(s)/Importation Authorisation submissions as required Support sustaining operations, including but not limited to: Qualified Person release of IMP's in accordance with BMS procedures and regulatory requirements Provide support to Health Authority GMP/GDP inspections and audits across the supply chain Advise stakeholders on quality issue management and process enhancement/compliance, ensuring consistent quality standards and fostering strong working relationships Incorporate global regulatory trends and changes into Supply Chain Quality. Support Site Master File maintenance Oversee Manufacturer(s)/Importation Authorisation update and maintenance Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management Review and approve procedural documents Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level May influence the external environment through interactions with regulators, trade associations, or professional societies Proactively identify risk areas Provide input in the global audit plans based on identified signals/trends/risks/gaps Supervise QA personnel as assigned Undergo continuous professional development including self-study, site visits, internal and external training courses and audits Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives Supporting People with Disabilities Education/Experience/ Licenses/Certifications: University degree (science degree preferred). Eligibility to act as an EU Qualified Person i.e. either an EU Pharmacy degree or other equivalent qualification. Experience as a Qualified Person desirable. Experience in communicating with regulatory authorities and making significant quality decisions
About the Role/Company
- The company supports start-up activities for Clinical Supply Chain Quality in Dublin
- The company values continuous quality improvement and efficiency initiatives
- The company supports people with disabilities
Key Responsibilities
- Review and approve QA/QP related procedures
- Support preparation and approval of training materials
- Support review and approval of Quality Agreements
- Ensure knowledge transfer from current release site
- Support Manufacturer(s)/Importation Authorisation submissions
- Perform Qualified Person release of IMP's in accordance with BMS procedures and regulatory requirements
- Provide support to Health Authority GMP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Support Site Master File maintenance
- Oversee Manufacturer(s)/Importation Authorisation update and maintenance
- Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management
- Review and approve procedural documents
- Participate in multidisciplinary or cross-functional work/project teams
- Serve as part of strategic team(s) within the group/discipline
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
- Influence the external environment through interactions with regulators, trade associations, or professional societies
- Proactively identify risk areas
- Provide input in the global audit plans based on identified signals/trends/risks/gaps
- Supervise QA personnel as assigned
- Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
- Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives
Required Qualifications
- University degree (science degree preferred)
- Eligibility to act as an EU Qualified Person (EU Pharmacy degree or other equivalent qualification)
Preferred Qualifications
- Experience as a Qualified Person
- Experience in communicating with regulatory authorities and making significant quality decisions
Skills Required
- Strong communication skills for interacting with regulatory authorities and stakeholders
- Ability to make significant quality decisions
- Leadership skills to supervise QA personnel
- Analytical skills to identify risk areas and provide input on audit plans
- Ability to foster strong working relationships
- Proactive approach to continuous professional development
Locations
- Dublin, IE
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
80,000 - 120,000 EUR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong communication skills for interacting with regulatory authorities and stakeholdersintermediate
- Ability to make significant quality decisionsintermediate
- Leadership skills to supervise QA personnelintermediate
- Analytical skills to identify risk areas and provide input on audit plansintermediate
- Ability to foster strong working relationshipsintermediate
- Proactive approach to continuous professional developmentintermediate
Required Qualifications
- University degree (science degree preferred) (experience)
- Eligibility to act as an EU Qualified Person (EU Pharmacy degree or other equivalent qualification) (experience)
Preferred Qualifications
- Experience as a Qualified Person (experience)
- Experience in communicating with regulatory authorities and making significant quality decisions (experience)
Responsibilities
- Review and approve QA/QP related procedures
- Support preparation and approval of training materials
- Support review and approval of Quality Agreements
- Ensure knowledge transfer from current release site
- Support Manufacturer(s)/Importation Authorisation submissions
- Perform Qualified Person release of IMP's in accordance with BMS procedures and regulatory requirements
- Provide support to Health Authority GMP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Support Site Master File maintenance
- Oversee Manufacturer(s)/Importation Authorisation update and maintenance
- Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management
- Review and approve procedural documents
- Participate in multidisciplinary or cross-functional work/project teams
- Serve as part of strategic team(s) within the group/discipline
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
- Influence the external environment through interactions with regulators, trade associations, or professional societies
- Proactively identify risk areas
- Provide input in the global audit plans based on identified signals/trends/risks/gaps
- Supervise QA personnel as assigned
- Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
- Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives
Tags & Categories
Senior Manager, CSCQ, Qualified Person
Bristol-Myers Squibb
Senior Manager, CSCQ, Qualified Person
Job Description
Support start-up activities for Clinical Supply Chain Quality Dublin, including but not limited to: Review and approval of QA/QP related procedures Support preparation and approval of training materials Support review and approval of Quality Agreements Ensure knowledge transfer from current release site Support Manufacturer(s)/Importation Authorisation submissions as required Support sustaining operations, including but not limited to: Qualified Person release of IMP's in accordance with BMS procedures and regulatory requirements Provide support to Health Authority GMP/GDP inspections and audits across the supply chain Advise stakeholders on quality issue management and process enhancement/compliance, ensuring consistent quality standards and fostering strong working relationships Incorporate global regulatory trends and changes into Supply Chain Quality. Support Site Master File maintenance Oversee Manufacturer(s)/Importation Authorisation update and maintenance Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management Review and approve procedural documents Participate in multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level May influence the external environment through interactions with regulators, trade associations, or professional societies Proactively identify risk areas Provide input in the global audit plans based on identified signals/trends/risks/gaps Supervise QA personnel as assigned Undergo continuous professional development including self-study, site visits, internal and external training courses and audits Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives Supporting People with Disabilities Education/Experience/ Licenses/Certifications: University degree (science degree preferred). Eligibility to act as an EU Qualified Person i.e. either an EU Pharmacy degree or other equivalent qualification. Experience as a Qualified Person desirable. Experience in communicating with regulatory authorities and making significant quality decisions
About the Role/Company
- The company supports start-up activities for Clinical Supply Chain Quality in Dublin
- The company values continuous quality improvement and efficiency initiatives
- The company supports people with disabilities
Key Responsibilities
- Review and approve QA/QP related procedures
- Support preparation and approval of training materials
- Support review and approval of Quality Agreements
- Ensure knowledge transfer from current release site
- Support Manufacturer(s)/Importation Authorisation submissions
- Perform Qualified Person release of IMP's in accordance with BMS procedures and regulatory requirements
- Provide support to Health Authority GMP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Support Site Master File maintenance
- Oversee Manufacturer(s)/Importation Authorisation update and maintenance
- Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management
- Review and approve procedural documents
- Participate in multidisciplinary or cross-functional work/project teams
- Serve as part of strategic team(s) within the group/discipline
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
- Influence the external environment through interactions with regulators, trade associations, or professional societies
- Proactively identify risk areas
- Provide input in the global audit plans based on identified signals/trends/risks/gaps
- Supervise QA personnel as assigned
- Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
- Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives
Required Qualifications
- University degree (science degree preferred)
- Eligibility to act as an EU Qualified Person (EU Pharmacy degree or other equivalent qualification)
Preferred Qualifications
- Experience as a Qualified Person
- Experience in communicating with regulatory authorities and making significant quality decisions
Skills Required
- Strong communication skills for interacting with regulatory authorities and stakeholders
- Ability to make significant quality decisions
- Leadership skills to supervise QA personnel
- Analytical skills to identify risk areas and provide input on audit plans
- Ability to foster strong working relationships
- Proactive approach to continuous professional development
Locations
- Dublin, IE
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
80,000 - 120,000 EUR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong communication skills for interacting with regulatory authorities and stakeholdersintermediate
- Ability to make significant quality decisionsintermediate
- Leadership skills to supervise QA personnelintermediate
- Analytical skills to identify risk areas and provide input on audit plansintermediate
- Ability to foster strong working relationshipsintermediate
- Proactive approach to continuous professional developmentintermediate
Required Qualifications
- University degree (science degree preferred) (experience)
- Eligibility to act as an EU Qualified Person (EU Pharmacy degree or other equivalent qualification) (experience)
Preferred Qualifications
- Experience as a Qualified Person (experience)
- Experience in communicating with regulatory authorities and making significant quality decisions (experience)
Responsibilities
- Review and approve QA/QP related procedures
- Support preparation and approval of training materials
- Support review and approval of Quality Agreements
- Ensure knowledge transfer from current release site
- Support Manufacturer(s)/Importation Authorisation submissions
- Perform Qualified Person release of IMP's in accordance with BMS procedures and regulatory requirements
- Provide support to Health Authority GMP/GDP inspections and audits across the supply chain
- Advise stakeholders on quality issue management and process enhancement/compliance
- Incorporate global regulatory trends and changes into Supply Chain Quality
- Support Site Master File maintenance
- Oversee Manufacturer(s)/Importation Authorisation update and maintenance
- Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management
- Review and approve procedural documents
- Participate in multidisciplinary or cross-functional work/project teams
- Serve as part of strategic team(s) within the group/discipline
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
- Influence the external environment through interactions with regulators, trade associations, or professional societies
- Proactively identify risk areas
- Provide input in the global audit plans based on identified signals/trends/risks/gaps
- Supervise QA personnel as assigned
- Undergo continuous professional development including self-study, site visits, internal and external training courses and audits
- Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives
Tags & Categories