Associate Director Quality Control, Microbiology
Bristol Myers Squibb
5 hours ago
On-site
Devens, MA
Operations
PRINCIPAL OBJECTIVE OF THE POSITION
Associate Director, Quality Control Microbiology Laboratory Operations provides strategic leadership, governance, and GMP-compliant execution of microbiological quality control activities supporting commercial and clinical biologics manufacturing at the Devens site to protect patient safety, product quality, and data integrity.
Major Duties and Responsibilities
- Provide strategic/operational leadership for GMP Microbiology activities (environmental/utility monitoring, sterility assurance, microbial testing, microbiological release support).
- Establish/maintain laboratory governance, performance metrics, and continuous improvement initiatives.
- Execute laboratory work per approved procedures, validated methods, regulatory filings, and internal quality standards.
- Drive/participate in compliance-related teams for continuous improvement and operational excellence.
- Lead microbiology deviations, investigations, CAPAs, and change controls.
- Maintain continuous inspection readiness; serve as lab SME during regulatory inspections, customer audits, and internal audits.
- Provide independent quality judgment; escalate quality risks to governance forums.
Knowledge/Skills
- Expert GMP microbiology, sterility assurance, environmental monitoring, and biologics manufacturing controls.
- Strong understanding of global regulatory expectations (e.g., FDA, EMA) and data integrity.
- Quality risk management, investigation methodologies, inspection readiness.
- Ability to lead GMP-impacting teams and influence cross-functional partners.
Qualifications
- Required: Bachelor’s in Microbiology/Biology/Life Sciences or related field; 10+ years GMP microbiology/quality control lab operations experience (pharma/biotech); demonstrated leadership managing GMP labs/teams/quality systems.
- Preferred: Master’s/PhD; experience with commercial sterile biologics manufacturing and regulatory inspections; experience overseeing contract laboratories/external GMP providers.
Compensation/Benefits (as stated)
- Devens, MA: US $173,280–$209,976.
- Health coverage; wellbeing programs; 401(k); disability/life/insurance; paid time off and flexible time off/vacation options (eligibility-based).
Application instructions
- If the role doesn’t perfectly match your resume, apply anyway.
Associate Director, Quality Control Microbiology Laboratory Operations provides strategic leadership, governance, and GMP-compliant execution of microbiological quality control activities supporting commercial and clinical biologics manufacturing at the Devens site to protect patient safety, product quality, and data integrity.
Major Duties and Responsibilities
- Provide strategic/operational leadership for GMP Microbiology activities (environmental/utility monitoring, sterility assurance, microbial testing, microbiological release support).
- Establish/maintain laboratory governance, performance metrics, and continuous improvement initiatives.
- Execute laboratory work per approved procedures, validated methods, regulatory filings, and internal quality standards.
- Drive/participate in compliance-related teams for continuous improvement and operational excellence.
- Lead microbiology deviations, investigations, CAPAs, and change controls.
- Maintain continuous inspection readiness; serve as lab SME during regulatory inspections, customer audits, and internal audits.
- Provide independent quality judgment; escalate quality risks to governance forums.
Knowledge/Skills
- Expert GMP microbiology, sterility assurance, environmental monitoring, and biologics manufacturing controls.
- Strong understanding of global regulatory expectations (e.g., FDA, EMA) and data integrity.
- Quality risk management, investigation methodologies, inspection readiness.
- Ability to lead GMP-impacting teams and influence cross-functional partners.
Qualifications
- Required: Bachelor’s in Microbiology/Biology/Life Sciences or related field; 10+ years GMP microbiology/quality control lab operations experience (pharma/biotech); demonstrated leadership managing GMP labs/teams/quality systems.
- Preferred: Master’s/PhD; experience with commercial sterile biologics manufacturing and regulatory inspections; experience overseeing contract laboratories/external GMP providers.
Compensation/Benefits (as stated)
- Devens, MA: US $173,280–$209,976.
- Health coverage; wellbeing programs; 401(k); disability/life/insurance; paid time off and flexible time off/vacation options (eligibility-based).
Application instructions
- If the role doesn’t perfectly match your resume, apply anyway.