Senior Manager, Quality Assurance - Lab Operations
Bristol-Myers Squibb
Senior Manager, Quality Assurance - Lab Operations
Job Description
Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies. Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data. Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations. Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions. Manage and mentor a team of QA professionals supporting lab operations. Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents. Participate in internal audits and regulatory inspections as a QA representative and subject matter expert. Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture. 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. Supporting People with Disabilities Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare). Strong leadership, communication, and interpersonal skills. Ability to manage multiple priorities in a fast-paced environment. Experience supporting regulatory inspections (FDA, EMA, etc.). Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field. 8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment. 3+ years of leadership or management experience. Strong understanding of analytical testing, method validation, and stability programs for biologics. In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles.
Key Responsibilities
- Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies
- Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data
- Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations
- Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions
- Manage and mentor a team of QA professionals supporting lab operations
- Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents
- Participate in internal audits and regulatory inspections as a QA representative and subject matter expert
- Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture
Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field
- + years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment
- + years of leadership or management experience
- Strong understanding of analytical testing, method validation, and stability programs for biologics
- In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles
Preferred Qualifications
- Experience supporting regulatory inspections (FDA, EMA, etc.)
- Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare)
Skills Required
- Strong leadership skills
- Effective communication skills
- Strong interpersonal skills
- Ability to manage multiple priorities in a fast-paced environment
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
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong leadership skillsintermediate
- Effective communication skillsintermediate
- Strong interpersonal skillsintermediate
- Ability to manage multiple priorities in a fast-paced environmentintermediate
Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field (experience)
- + years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment (experience)
- + years of leadership or management experience (experience)
- Strong understanding of analytical testing, method validation, and stability programs for biologics (experience)
- In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles (experience)
Preferred Qualifications
- Experience supporting regulatory inspections (FDA, EMA, etc.) (experience)
- Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare) (experience)
Responsibilities
- Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies
- Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data
- Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations
- Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions
- Manage and mentor a team of QA professionals supporting lab operations
- Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents
- Participate in internal audits and regulatory inspections as a QA representative and subject matter expert
- Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture
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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Senior Manager, Quality Assurance - Lab Operations
Bristol-Myers Squibb
Senior Manager, Quality Assurance - Lab Operations
Job Description
Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies. Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data. Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations. Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions. Manage and mentor a team of QA professionals supporting lab operations. Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents. Participate in internal audits and regulatory inspections as a QA representative and subject matter expert. Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture. 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. Supporting People with Disabilities Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare). Strong leadership, communication, and interpersonal skills. Ability to manage multiple priorities in a fast-paced environment. Experience supporting regulatory inspections (FDA, EMA, etc.). Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field. 8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment. 3+ years of leadership or management experience. Strong understanding of analytical testing, method validation, and stability programs for biologics. In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles.
Key Responsibilities
- Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies
- Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data
- Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations
- Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions
- Manage and mentor a team of QA professionals supporting lab operations
- Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents
- Participate in internal audits and regulatory inspections as a QA representative and subject matter expert
- Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture
Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field
- + years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment
- + years of leadership or management experience
- Strong understanding of analytical testing, method validation, and stability programs for biologics
- In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles
Preferred Qualifications
- Experience supporting regulatory inspections (FDA, EMA, etc.)
- Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare)
Skills Required
- Strong leadership skills
- Effective communication skills
- Strong interpersonal skills
- Ability to manage multiple priorities in a fast-paced environment
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
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong leadership skillsintermediate
- Effective communication skillsintermediate
- Strong interpersonal skillsintermediate
- Ability to manage multiple priorities in a fast-paced environmentintermediate
Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field (experience)
- + years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment (experience)
- + years of leadership or management experience (experience)
- Strong understanding of analytical testing, method validation, and stability programs for biologics (experience)
- In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles (experience)
Preferred Qualifications
- Experience supporting regulatory inspections (FDA, EMA, etc.) (experience)
- Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare) (experience)
Responsibilities
- Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies
- Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data
- Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations
- Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions
- Manage and mentor a team of QA professionals supporting lab operations
- Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents
- Participate in internal audits and regulatory inspections as a QA representative and subject matter expert
- Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture
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 Senior Manager, Quality Assurance - Lab Operations @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs