About the Role
The Senior QA Manager will be responsible for owning cGMP compliance, driving continuous improvement, and mentoring a growing QA/QC team within a nimble, fast-paced API environment.
Key Activities
Compliance & Audits - Serve as site owner for all regulatory, third-party, and customer audits (FDA, EMA, ISO, DEA).
Lead PAI readiness: gap assessments, CAPA execution, mock inspections, and front-room/back-room strategy.
Maintain and enhance the QMS: change control, deviations, investigations, CAPA, document control, supplier qualification, and training.
Generate and track quality KPIs; present monthly to executive leadership.
Direct and mentor a team of QA Specialists, QC Analysts, and external consultants.
Foster a proactive, right-first-time culture; coach cross-functional teams on GMP best practices.
Approve master batch records, specifications, analytical methods, and validation protocols (process, cleaning, equipment, computer systems).
Drive Lean Six Sigma projects to reduce deviations, improve yield, and shorten release cycles.
Champion data integrity (ALCOA+) across manufacturing and laboratory systems.
Perform and oversee quality risk assessments (ICH Q9) and supplier audits.
Preferred Skills
ASQ, CQA, CPGP, or Six Sigma (Green/Black Belt) a plus.
Education and Experience
BS/BA in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field (MS preferred).
8+ years’ progressive QA/QC leadership in cGMP pharmaceutical or chemical API manufacturing.
Demonstrated success preparing for and hosting FDA/EMA PAIs and routine GMP audits.
Hands-on expertise with ICH Q7, Q9, Q10, 21CFR Parts 210/211/11, and data integrity guidelines.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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