Director, QC & Microbiology

Socket.dev; San Diego (CA); On-site; USD 151,000 - 189,000; Full time

Benefits offered by this job

Paid time off

Health insurance

FSA

401(k)

Job summary

PCI Pharma Services seeks a Director of QC & Microbiology to lead strategic and operational aspects of Quality Control Chemistry and Microbiology. You will ensure regulatory compliance, laboratory capacity, and organizational capability to support current operations and growth.

This role requires strong technical and people leadership, with responsibility for inspections, investigations, and continuous improvement.

Qualifications

• Bachelor's degree required; MS/PhD preferred.
• Typically 12+ years pharma/biotech/CDMO lab leadership.
• Experience overseeing large departments and GMP environments.
• Subject matter expert in regulatory inspections and client audits.
• Experience with LIMS, CDS, SDMS systems.

Responsibilities

• Set strategy for QC Chemistry and Microbiology aligned with site priorities.
• Ensure staffing, capacity, instrumentation, and capabilities for current and future operations.
• Lead budgeting, capital investments, and resource allocation.
• Represent QC and Microbiology in inspections, audits, and governance.
• Oversee testing across raw materials, in-process, release, stability, and environmental monitoring.
• Validate and transfer analytical methods; manage OOS/OOT investigations and deviations.
• Maintain data integrity and ensure compliance across lab records and reports.
• Drive lab modernization, automation, and continuous improvement initiatives.
• Develop leaders and build a high-performing QC/Microbiology organization.

Skills

Leadership

Strategic planning

Quality systems

Regulatory inspections

Data integrity

Environmental monitoring

Analytical testing

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or life sciences

MS or PhD degree preferred

Tools

LIMS

CDS

SDMS

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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 Responsibilities

Strategic 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 escalating 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).

#LI-AL1

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.