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Summary:
The Senior Director, Quality Control and Microbiology leads the site’s laboratory strategy and performance within a multi-client CDMO environment. The role is accountable for QC Chemistry, Microbiology, Method Transfer, Stability, Raw Materials, Sample and Laboratory Logistics, and associated laboratory systems supporting GMP manufacturing and product release.
Reporting to the Executive Director, Site Quality Head, this leader sets the long-term technical and organizational direction for the laboratories and translates business priorities into executable capacity, staffing and investment plans. The role leads through managers and technical leaders, establishes clear accountability across functions, and ensures testing and scientific decisions protect patient safety, product quality and data integrity.
The Senior Director serves as the senior laboratory partner to site leadership and customers, leads resolution of complex laboratory and microbiological risks, and sponsors sustained improvements in testing reliability and turnaround time. Accountability includes laboratory budgets, capital priorities, succession planning and inspection readiness. Quality decisions and approvals follow approved procedures and delegated authority.
Key Responsibilities
- Laboratory strategy and business planning
- Establish the QC and Microbiology strategy and multiyear roadmap, aligning laboratory capabilities with site priorities, client programs and anticipated demand.
- Own laboratory operating budgets, workforce planning and capital investment recommendations. Prioritize spending using quality risk, capacity requirements and business impact.
- Lead capacity and capability reviews covering internal laboratories and external testing partners. Resolve constraints and maintain contingency plans for critical testing.
- Represent laboratory priorities in site leadership reviews and partner with network Quality leaders to align standards and share technical capabilities.
- Lead multiple site-wide laboratory strategy, standardization, and long term capability planning to support business growth, evolving client requirements, and enterprise quality objectives.
- Drive laboratory financial performance through capital investment prioritization, return on investment analysis, resource optimization, and productivity improvements aligned with site and enterprise business 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.
- Lead the resolution of critical laboratory quality risks and complex regulatory issues, partnering with executive leadership and key clients to mitigate business impact, protect product quality, and ensure business continuity.
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.
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 related field required; advanced degree preferred.
- Typically 15 or more years of progressive pharmaceutical, biotechnology, or CDMO laboratory experience, or an equivalent combination of education and relevant experience.
- Significant leadership experience in QC Chemistry, Microbiology, or both within a GMP-regulated environment.
- Experience with analytical testing, microbiological control, environmental monitoring, method transfer, stability, investigations, and data integrity.
- Demonstrated experience supporting 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 preferred.
The base salary hiring range for the Director, QC & Microbiology position is $171,040 - $192,420 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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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.
