Associate Director Quality Control, Microbiology
Bristol Myers Squibb
9 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. Ensures microbiology lab operations, systems, and personnel meet regulatory requirements, internal QMS standards, and inspection readiness expectations to protect patient safety, product quality, and data integrity.
Major Duties and Responsibilities
- Provide strategic/operational leadership for GMP microbiology lab activities (environmental & utility monitoring, sterility assurance, microbial testing, microbiological release support).
- Establish/maintain laboratory governance, performance metrics, and continuous improvement initiatives.
- Execute activities per approved procedures, validated methods, regulatory filings, and internal quality standards.
- Drive/participate in compliance teams and initiatives for continuous improvement.
- Accountable leader for microbiology deviations, investigations, CAPAs, and change controls.
- Maintain continuous inspection readiness; serve as laboratory SME for regulatory inspections, customer audits, and internal audits.
- Provide independent quality judgment and escalate quality risks.
Knowledge and Skill
- Expert GMP microbiology/sterility assurance, environmental monitoring, and biologics manufacturing controls.
- Strong understanding of global regulatory expectations (e.g., FDA, EMA) for microbiological QC and data integrity.
- Ability to lead GMP-impacting teams and influence cross-functional partners.
- Proficiency in quality risk management, investigation methodologies, and inspection readiness.
Qualifications
Required:
- Bachelor’s degree in Microbiology, Biology, Life Sciences, or related.
- Minimum 10 years progressive GMP microbiology/quality control lab operations in pharma/biotech.
- Demonstrated leadership managing GMP labs, teams, and quality systems.
Preferred:
- Master’s/PhD in Microbiology or related.
- Experience supporting commercial (sterile) biologics manufacturing and regulatory inspections.
- Experience overseeing contract laboratories/external GMP service providers.
Inspection Readiness Expectations
- Maintain continuous inspection readiness for labs, systems, and documentation.
- Ensure training, procedural compliance, and data integrity are inspection-ready.
- Lead inspection preparation, execution support, and response development.
Compensation Overview
Devens, MA: US $173,280 - $209,976 (full-time range).
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. Ensures microbiology lab operations, systems, and personnel meet regulatory requirements, internal QMS standards, and inspection readiness expectations to protect patient safety, product quality, and data integrity.
Major Duties and Responsibilities
- Provide strategic/operational leadership for GMP microbiology lab activities (environmental & utility monitoring, sterility assurance, microbial testing, microbiological release support).
- Establish/maintain laboratory governance, performance metrics, and continuous improvement initiatives.
- Execute activities per approved procedures, validated methods, regulatory filings, and internal quality standards.
- Drive/participate in compliance teams and initiatives for continuous improvement.
- Accountable leader for microbiology deviations, investigations, CAPAs, and change controls.
- Maintain continuous inspection readiness; serve as laboratory SME for regulatory inspections, customer audits, and internal audits.
- Provide independent quality judgment and escalate quality risks.
Knowledge and Skill
- Expert GMP microbiology/sterility assurance, environmental monitoring, and biologics manufacturing controls.
- Strong understanding of global regulatory expectations (e.g., FDA, EMA) for microbiological QC and data integrity.
- Ability to lead GMP-impacting teams and influence cross-functional partners.
- Proficiency in quality risk management, investigation methodologies, and inspection readiness.
Qualifications
Required:
- Bachelor’s degree in Microbiology, Biology, Life Sciences, or related.
- Minimum 10 years progressive GMP microbiology/quality control lab operations in pharma/biotech.
- Demonstrated leadership managing GMP labs, teams, and quality systems.
Preferred:
- Master’s/PhD in Microbiology or related.
- Experience supporting commercial (sterile) biologics manufacturing and regulatory inspections.
- Experience overseeing contract laboratories/external GMP service providers.
Inspection Readiness Expectations
- Maintain continuous inspection readiness for labs, systems, and documentation.
- Ensure training, procedural compliance, and data integrity are inspection-ready.
- Lead inspection preparation, execution support, and response development.
Compensation Overview
Devens, MA: US $173,280 - $209,976 (full-time range).