Summary:The Director, QC & Microbiology provides strategic and operational leadership for the site's Quality Control Chemistry and Microbiology functions, ensuring scientific excellence, regulatory compliance, laboratory capacity, and organizational capability support current operations and future growth. This leader oversees laboratory performance, analytical and microbiological testing, environmental monitoring, investigations, laboratory systems, and continuous improvement while serving as a key partner to site leadership and cross-functional teams. The role requires a strong combination of technical expertise, regulatory and GMP experience, strategic decision-making, and people leadership to build a high-performing organization, maintain inspection readiness, drive laboratory modernization and operational excellence, and proactively manage quality, compliance, capacity, and business risks.
Key ResponsibilitiesStrategic and Operational Leadership
- Establish and execute the strategy for QC Chemistry and Microbiology in alignment with site and company priorities.
- Ensure staffing, laboratory capacity, instrumentation, and technical capabilities support current operations and future growth.
- Lead laboratory performance, budget planning, capital investment, and resource allocation.
- Represent QC and Microbiology during regulatory inspections, client audits, governance meetings, and leadership reviews.
- Partner across Quality, Manufacturing, Validation, Engineering, Supply Chain, and Technical Services to support site objectives.
Quality Control and Microbiology Oversight
- Oversee raw material, in-process, release, stability, environmental, utility, and microbiological testing.
- Ensure analytical and microbiological methods are appropriately validated, transferred, maintained, and scientifically sound.
- Provide oversight of OOS, OOT, atypical results, environmental excursions, contamination events, and laboratory investigations.
- Maintain effective microbiological control, environmental monitoring, and contamination control programs.
- Ensure laboratory data, records, and reports are complete, accurate, timely, and compliant.
- Provide governance for contract laboratories and external testing partners.
Compliance and Laboratory Systems
- Maintain continuous inspection readiness and compliance with GMP requirements, procedures, regulatory commitments, and quality agreements.
- Strengthen laboratory data integrity and oversight of LIMS, CDS, SDMS, and other electronic systems.
- Ensure equipment, instruments, and laboratory systems are qualified, calibrated, maintained, and reliable.
- Drive timely closure of deviations, CAPAs, audit actions, and regulatory commitments.
- Lead laboratory modernization, automation, standardization, and continuous improvement initiatives.
People Leadership
- Build and lead an accountable, engaged, and technically capable QC and Microbiology organization.
- Develop managers, supervisors, technical leaders, and succession plans for critical roles.
- Establish clear priorities, decision rights, expectations, and escalation pathways.
- Foster a culture of scientific rigor, collaboration, ownership, and continuous improvement.
- Address performance issues promptly and recognize exceptional contributions.
Leadership Expectations
- Model PCI leadership behaviors and demonstrate integrity, accountability, and sound scientific judgment.
- Make timely, risk-based decisions and communicate complex issues clearly.
- Lead effectively through change, competing priorities, and operational pressure.
- Build trust across functions through transparency, collaboration, and consistent execution.
- Proactively identify and escalate quality, compliance, capacity, and business risks.
- Develop future leaders and strengthen organizational capability.
- Provide leadership to ensure continual improvement and compliance with EHS policies and procedures.
- Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
This role carries significant responsibility for maintaining compliance with safety, health, and environmental requirements through individual actions and leadership behaviors. Off-shift, weekend, and overtime support may be required based on business needs.
This job description is not intended to be all-inclusive. Duties, responsibilities, and activities may change or be assigned at any time with or without notice.
Qualifications: - Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a life sciences field required; MS or PhD degree preferred.
- Typically 12 or more years of progressive pharmaceutical, biotechnology, or CDMO laboratory experience.
- Experience overseeing large departments including direct and indirect reports.
- Significant leadership experience in QC Chemistry and Microbiology, within a GMP-regulated environment.
- Experience with analytical testing, microbiological control, environmental monitoring, method transfer, stability, investigations, and data integrity.
- Demonstrated experience as subject matter expert in regulatory inspections, client audits, and compliance remediation.
- Experience with laboratory electronic systems, including LIMS, CDS, and SDMS.
- Strong strategic, technical, people-leadership, communication, and decision-making skills.
- Experience in sterile, biologic, parenteral, or multi-client CDMO operations highly preferred.
The base salary hiring range for the Director, QC & Microbiology position is $151,360 - $189,200 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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