Sr. Specialist, External Manufacturing Quality Assurance
Bristol-Myers Squibb
Sr. Specialist, External Manufacturing Quality Assurance
Job Description
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations. Develops and implements policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution in accordance with organizational strategy and business realities. Ensures approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements. Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners. Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication, support, and guidance to manufacturing partners and within the QA team. Effectively communicatee issues, risks and proposed solutions within the organization. Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry. Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable Quality experience will be considered Expertise in GMP, Quality, material and product disposition Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management Strong project management skills and organizational ability to follow projects through to completion Team player who can work independently to achieve objectives in a fast-paced environment Excellent verbal and written communication skills. Audit and inspection management experience. Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired. Knowledge of US, EU and rest-of-world cGMP regulations and guidance. Knowledge and proven experience in FDA, EMA, or other regulatory authority. Demonstrated leadership, interpersonal, communication, and motivation skills. Previous work responsibility, which required a high degree of attention to detail. Well-practiced in exercising sound judgment in decision-making. Demonstrated prioritization and organization skills.
About the Role/Company
- RayzeBio is focused on maintaining quality standards and regulatory requirements in its operations
Key Responsibilities
- Support Quality disposition process by ensuring all required documents are accurately and properly completed and compiled against approved procedures and specifications
- Develop and implement policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution
- Ensure approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements
- Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners
- Work cross-functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners
- Provide communication, support, and guidance to manufacturing partners and within the QA team
- Effectively communicate issues, risks, and proposed solutions within the organization
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product
Required Qualifications
- BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas)
- Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing
- Knowledge and proven experience in FDA, EMA, or other regulatory authority
Skills Required
- Expertise in GMP, Quality, material and product disposition
- Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
- Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
- Strong project management skills and organizational ability to follow projects through to completion
- Team player who can work independently to achieve objectives in a fast-paced environment
- Excellent verbal and written communication skills
- Audit and inspection management experience
- Knowledge of US, EU and rest-of-world cGMP regulations and guidance
- Demonstrated leadership, interpersonal, communication, and motivation skills
- High degree of attention to detail
- Well-practiced in exercising sound judgment in decision-making
- Demonstrated prioritization and organization skills
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Indianapolis RayzeBio, India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Expertise in GMP, Quality, material and product dispositionintermediate
- Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principlesintermediate
- Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from managementintermediate
- Strong project management skills and organizational ability to follow projects through to completionintermediate
- Team player who can work independently to achieve objectives in a fast-paced environmentintermediate
- Excellent verbal and written communication skillsintermediate
- Audit and inspection management experienceintermediate
- Knowledge of US, EU and rest-of-world cGMP regulations and guidanceintermediate
- Demonstrated leadership, interpersonal, communication, and motivation skillsintermediate
- High degree of attention to detailintermediate
- Well-practiced in exercising sound judgment in decision-makingintermediate
- Demonstrated prioritization and organization skillsintermediate
Required Qualifications
- BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) (experience)
- Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry (experience)
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations (experience)
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing (experience)
- Knowledge and proven experience in FDA, EMA, or other regulatory authority (experience)
Responsibilities
- Support Quality disposition process by ensuring all required documents are accurately and properly completed and compiled against approved procedures and specifications
- Develop and implement policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution
- Ensure approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements
- Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners
- Work cross-functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners
- Provide communication, support, and guidance to manufacturing partners and within the QA team
- Effectively communicate issues, risks, and proposed solutions within the organization
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Sr. Specialist, External Manufacturing Quality Assurance
Bristol-Myers Squibb
Sr. Specialist, External Manufacturing Quality Assurance
Job Description
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations. Develops and implements policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution in accordance with organizational strategy and business realities. Ensures approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements. Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners. Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication, support, and guidance to manufacturing partners and within the QA team. Effectively communicatee issues, risks and proposed solutions within the organization. Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry. Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable Quality experience will be considered Expertise in GMP, Quality, material and product disposition Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management Strong project management skills and organizational ability to follow projects through to completion Team player who can work independently to achieve objectives in a fast-paced environment Excellent verbal and written communication skills. Audit and inspection management experience. Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired. Knowledge of US, EU and rest-of-world cGMP regulations and guidance. Knowledge and proven experience in FDA, EMA, or other regulatory authority. Demonstrated leadership, interpersonal, communication, and motivation skills. Previous work responsibility, which required a high degree of attention to detail. Well-practiced in exercising sound judgment in decision-making. Demonstrated prioritization and organization skills.
About the Role/Company
- RayzeBio is focused on maintaining quality standards and regulatory requirements in its operations
Key Responsibilities
- Support Quality disposition process by ensuring all required documents are accurately and properly completed and compiled against approved procedures and specifications
- Develop and implement policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution
- Ensure approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements
- Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners
- Work cross-functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners
- Provide communication, support, and guidance to manufacturing partners and within the QA team
- Effectively communicate issues, risks, and proposed solutions within the organization
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product
Required Qualifications
- BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas)
- Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing
- Knowledge and proven experience in FDA, EMA, or other regulatory authority
Skills Required
- Expertise in GMP, Quality, material and product disposition
- Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
- Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
- Strong project management skills and organizational ability to follow projects through to completion
- Team player who can work independently to achieve objectives in a fast-paced environment
- Excellent verbal and written communication skills
- Audit and inspection management experience
- Knowledge of US, EU and rest-of-world cGMP regulations and guidance
- Demonstrated leadership, interpersonal, communication, and motivation skills
- High degree of attention to detail
- Well-practiced in exercising sound judgment in decision-making
- Demonstrated prioritization and organization skills
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Indianapolis RayzeBio, India
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Expertise in GMP, Quality, material and product dispositionintermediate
- Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principlesintermediate
- Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from managementintermediate
- Strong project management skills and organizational ability to follow projects through to completionintermediate
- Team player who can work independently to achieve objectives in a fast-paced environmentintermediate
- Excellent verbal and written communication skillsintermediate
- Audit and inspection management experienceintermediate
- Knowledge of US, EU and rest-of-world cGMP regulations and guidanceintermediate
- Demonstrated leadership, interpersonal, communication, and motivation skillsintermediate
- High degree of attention to detailintermediate
- Well-practiced in exercising sound judgment in decision-makingintermediate
- Demonstrated prioritization and organization skillsintermediate
Required Qualifications
- BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) (experience)
- Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry (experience)
Preferred Qualifications
- Hands-on experience with QA oversight of contract manufacturing organizations (experience)
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing (experience)
- Knowledge and proven experience in FDA, EMA, or other regulatory authority (experience)
Responsibilities
- Support Quality disposition process by ensuring all required documents are accurately and properly completed and compiled against approved procedures and specifications
- Develop and implement policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution
- Ensure approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements
- Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners
- Work cross-functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners
- Provide communication, support, and guidance to manufacturing partners and within the QA team
- Effectively communicate issues, risks, and proposed solutions within the organization
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Sr. Specialist, External Manufacturing Quality Assurance @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs