Job Title: Associate Director, Quality Operations
The Associate Director, Quality Operations will report to the Associate Director, QA Operation Schachen Biologics and play a crucial role in supporting clinical quality activities at our Werthenstein site. This position carries the responsibility for ensuring compliance with Good Manufacturing Practices (GMP) and overseeing clinical supply functions to maintain adherence to relevant regulations for clinical drug substances.
Key Responsibilities:
- Manage and execute quality activities to ensure compliance with cGMPs, global regulations, and company standards for supported areas.
- Provide senior management with assessments regarding compliance status and risk levels, and offer guidance on aligning policies with regulatory expectations.
- Stay informed about current GMP requirements and industry trends. Communicate regulatory impacts to client areas and maintain expert knowledge in specialized technical areas.
- Ensure departmental SOPs accurately reflect procedures and current regulations, and oversee updates as necessary.
- Manage the review and approval of GMP documentation related to regulatory filings, clinical supplies, and equipment qualification, ensuring adherence to requirements.
- Coordinate preparations for regulatory agency inspections and accompany officials during inspections, including GMP Certification inspections. Draft responses to inspectional observations as needed.
- Advise on GMP compliance aspects related to facility design, equipment selection, SOP preparation, and quality practices.
- Act as the Quality representative for internal or external manufacturing programs, overseeing compliance-related activities, batch record approvals, and change management.
- Develop quality systems and policies for the Development Quality department as required.
- Participate actively in GMP audits and inspections, assessing deficiencies and their impact on compliance status.
- Notify management of any compliance issues and performance trends in supported areas.
Additional Skills and Competencies:
- Experience with integrated, automated operations (e.g., DeltaV, SAP, Manufacturing Execution System).
- Proficiency in drug substance manufacturing and leading Health Authority Inspections.
- Fluency in English and conversational German.
Required Experience and Skills:
- Experience in the pharmaceutical, biotech, or another regulated industry.
- Technical writing experience (investigations, laboratory reports, SOPs, etc.).
- Proven ability to conduct multiple investigations within deadlines.
- Demonstrated capacity to manage multiple projects and initiatives concurrently.
Your Profile:
- A Master’s Degree in Engineering, Sciences, or a related field, with at least five years of experience in a regulated industry.
- Experience with formal problem-solving techniques and hands-on approaches (e.g., Root Cause Analysis, Lean Six Sigma).
- cGMP experience in a sterile, vaccine, bulk, or finished goods pharmaceutical environment.
- Detailed understanding of Critical Process Parameters, Critical Quality Attributes, and equipment qualification principles.
About Us:
Our Company is a leading biopharmaceutical organization with over 1,000 employees across three sites in Switzerland. Headquartered in Lucerne, we operate a global innovation and development hub in Zurich, alongside a manufacturing site for clinical trial medicines in Schachen.
Committed to excellence, we conduct around 40 clinical trials annually in areas such as oncology and infectious diseases, and pride ourselves on a comprehensive portfolio of vaccines. Our dedication to the community is embodied by our long-standing involvement in initiatives like “Trendtage Gesundheit Luzern” and “Alliance Health Competence.”
Recognized as a “Top Employer Switzerland” and “Top Employer Europe,” we are dedicated to our employees and the community.
At our Werthenstein BioPharma site in Schachen, we engage in groundbreaking research and development of biological agents, while also providing clinical trial products globally. We safeguard our products through a meticulous supply chain process to ensure safety and reliability for our patients.
Apply online using the form below. Only applications matching the job profile will be considered.