Position Summary

The Director / Senior Director, Quality Control is responsible for leading QC Analytical Chemistry and QC Microbiology operations supporting sterile injectable manufacturing. This role oversees testing, product release, compliance, investigations, data integrity, environmental monitoring, and laboratory operations while ensuring GMP compliance, inspection readiness, and continuous improvement.

Key Responsibilities

Laboratory Leadership & Operations

• Lead QC Analytical Chemistry and Microbiology laboratories.
• Manage budgets, staffing, laboratory capacity, and capital investments.
• Establish QC KPIs and drive operational excellence.
• Recruit, mentor, and develop laboratory personnel.
• Promote a culture of quality, accountability, and continuous improvement.

Testing & Product Release

• Ensure timely testing and release of raw materials, in-process samples, finished products, and stability samples.
• Oversee raw material qualification, CoA verification, and USP/NF compliance.
• Partner with QA and Manufacturing to support batch release timelines.
• Review and approve analytical results and Certificates of Analysis.

Analytical Chemistry Oversight

• Oversee testing using HPLC/UPLC, GC, FTIR, UV-Vis, Karl Fischer, particulate testing, assay, impurity, and residual solvent methods.
• Lead method validation, verification, transfer, and lifecycle management.
• Manage reference standards, reagents, and stability programs.

Microbiology & Sterility Assurance

• Direct sterility, endotoxin, bioburden, microbial identification, and EM programs.
• Oversee monitoring of cleanrooms, utilities, and classified environments.
• Support media fills, aseptic process simulations, and contamination control initiatives.
• Ensure compliance with FDA aseptic guidance and EU GMP Annex 1.

Investigations & Compliance

• Lead OOS, OOT, deviation, and CAPA investigations.
• Ensure compliance with 21 CFR Parts 210/211, Part 11, USP, and GMP requirements.
• Maintain data integrity standards across all laboratory systems.
• Serve as QC SME during inspections, audits, and regulatory interactions.
• Drive inspection readiness and remediation activities.

Documentation & Vendor Management

• Approve SOPs, specifications, methods, protocols, and reports.
• Manage contract testing laboratories and quality agreements.
• Support APQRs, change controls, management reviews, and regulatory submissions.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related discipline.
• 10+ years of QC experience in pharmaceutical manufacturing.
• 5+ years of leadership experience in GMP-regulated laboratories.
• Strong experience with sterile injectables, analytical testing, microbiology, and environmental monitoring.
• In-depth knowledge of FDA, USP, GMP, and data integrity requirements.
• Experience supporting regulatory inspections and audits.

Preferred

• Master's or PhD in a scientific discipline.
• Experience in aseptic manufacturing or 503B outsourcing facilities.
• Experience with LIMS, Empower, and laboratory computerized systems.
• ASQ or relevant quality certifications.

Key Competencies

• Quality Control Leadership
• Analytical Chemistry
• Microbiology & Sterility Assurance
• GMP & Regulatory Compliance
• Data Integrity (ALCOA+)
• Investigation & CAPA Management
• Inspection Readiness
• Laboratory Operations
• People Leadership
• Continuous Improvement
• Strategic Planning
• Cross-Functional Collaboration

What Success Looks Like

• Consistent on-time product testing and release.
• Successful regulatory and customer inspections.
• Reduced deviations, OOS events, and EM excursions.
• High-performing and engaged QC team.
• Strong GMP, data integrity, and quality compliance.
• Efficient laboratory operations supporting manufacturing growth.