Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
Position Purpose
The QA Manager leads Quality Operations activities at the Lengnau site, ensuring compliance with cGMP requirements, regulatory expectations, internal Quality standards, and customer commitments.
The role provides leadership to the QA Operations team and Quality oversight across Manufacturing, QC, Supply Chain, and related operational functions. The QA Manager is accountable for product and process compliance decisions and ensures effective management of batch disposition, Quality events, APQRs, operational Quality oversight, and continuous improvement. The position works closely with site leadership, cross-functional teams, customers, auditors, and regulatory authorities and promotes a strong Quality Culture across the organization.
Key Responsibilities
- Lead, coach, and develop the QA Operations team, ensuring appropriate resources, priorities, and performance.
- Provide Quality leadership and independent, risk-based decision-making for operational and product-related matters.
- Ensure QA review and approval of master batch records, specifications, and relevant GMP documentation.
- Ensure timely batch disposition/release of raw materials, buffers, media, intermediates, and drug substances.
- Oversee Quality systems including deviations, change controls, CAPAs, complaints, OOS/OOT, and associated investigations.
- Review and approve method transfers, method validations, and specifications, as applicable.
- Lead APQR/PQR preparation and ensure timely completion and appropriate follow-up of identified trends and actions.
- Lead QA shop-floor/Gemba oversight and promote proactive identification and mitigation of Quality risks.
- Provide Quality oversight of Supply Chain activities, including material transfers, logistics, chain of custody, and shipment.
- Serve as a key QA contact for customers and support customer audits and regulatory inspections.
- Maintain inspection readiness and ensure timely resolution and escalation of significant Quality and compliance issues.
- Monitor Quality performance and trends and drive sustainable continuous improvement without compromising product quality or compliance.
- Participate in site and global Quality initiatives and promote a strong Quality Culture.
Education
- Master's degree in Life Sciences or a related scientific discipline preferred. Equivalent education and relevant experience may be considered.
Experience & Competencies
- Minimum 5 years of experience in Quality Assurance and/or GMP operations within the pharmaceutical or biopharmaceutical industry.
- Demonstrated people leadership/management experience in a GMP environment.
- Strong knowledge of biological pharmaceutical manufacturing, Quality systems, and cGMP requirements.
- Strong knowledge of relevant regulatory requirements, particularly Swissmedic, US FDA, EU GMP, and ICH guidelines.
- Experience with batch disposition, deviations, CAPAs, change controls, complaints, OOS/OOT, APQR/PQR, and operational Quality oversight.
- Experience supporting customer audits and regulatory inspections.
- Strong leadership, communication, stakeholder management, problem-solving, and risk-based decision-making skills.
- Ability to manage competing priorities and effectively collaborate across functions and organizational levels.
Additional Requirements
- Participation in the departmental on-call service, including second-level remote support, according to department organization.