Job Title: Associate Director, Quality Operations
The Associate Director, Quality Operations reports to the Associate Director, QA Operation Schachen Biologics and supports clinical quality activities at our Werthenstein site. This role is pivotal in ensuring Good Manufacturing Practice (GMP) compliance and that clinical supply functions operate within GMP requirements.
The successful candidate will drive and support compliance-based programs, manage complex projects, and implement current Good Manufacturing Practices (cGMP) quality initiatives. Key responsibilities include quality system improvements, managing compliance metrics and monitoring, as well as overseeing Standard Operating Procedure (SOP) management and related site procedures.
Essential Duties and Responsibilities:
- Lead and manage quality activities to ensure compliance with cGMPs and applicable worldwide regulations.
- Provide assessments to senior management regarding compliance status and offer guidance on policy alignment with regulatory expectations.
- Stay informed of current GMP requirements and industry trends, providing feedback on proposed regulations and their impacts.
- Ensure departmental SOPs are aligned with regulations and periodically updated.
- Review and approve GMP documentation for regulatory filings, clinical supply, development, and technology transfer.
- Prepare for regulatory agency inspections and accompany officials during inspections, drafting responses to inspectional observations.
- Advise on GMP compliance related to facility design, equipment selection, quality practices, and regulatory interpretations.
- Act as the Quality representative for internal or external manufacturing programs, overseeing compliance-related activities.
- Manage all activities within resource constraints while adhering to company policies and regulatory requirements.
- Develop quality systems and policies for the Development Quality department as needed.
- Represent the Development Quality in project teams or committees to establish GMP standards and policies.
- Participate in GMP audits/inspections of facilities, evaluating compliance status and addressing any audit findings.
- Notify management of compliance issues and performance trends.
Additional Skills and Competencies Considered a Strong Asset:
- Experience with automated, integrated operations (e.g., DeltaV, SAP, Manufacturing Execution System)
- Background in drug substance manufacturing.
- Experience in leading Health Authority Inspections.
- Fluency in English and conversational German.
Required Experience and Skills:
- Experience in pharmaceutical, biotech, or other regulated industries.
- Technical writing experience for investigations, reports, SOPs, and protocols.
- Ability to conduct multiple investigations within established deadlines.
- Demonstrated ability to manage multiple projects and initiatives effectively.
Involvement in Key Projects:
- Quality Local Lead for Major Companywide Efficiency Project, including implementing automated IT systems (EAM/MES PAS-X).
- QMS Redesign Topic Team Member for improving facility and Lab QMS.
- Participation in Due Diligence Projects to assist with the integration of new assets.
- Upskilling Less Experienced Staff to preserve knowledge and enhance team capabilities.
Your Profile:
Preferred Education, Experience, and Skills:
- A Master’s Degree in Engineering, Sciences, or a related field and at least five years of experience in the pharmaceutical, biotech, or another regulated industry.
- Experience with formal problem-solving techniques, such as Root Cause Analysis or Lean Six Sigma tools.
- cGMP experience in sterile, vaccine, or pharmaceutical environments.
- Understanding of Critical Process Parameters and Critical Quality Attributes.
About the Company:
Our Company is a leading biopharmaceutical entity employing over 1,000 people across three sites in Switzerland. The headquarters are located in Lucerne, with a global innovation and development hub operating in Zurich. Additionally, we manufacture medicines for global clinical trials and maintain a forensic laboratory in Schachen (Canton Lucerne), conducting approximately 40 clinical trials annually across various therapeutic areas, including oncology and infectious diseases.
We proudly hold certifications as a “Top Employer Switzerland” and “Top Employer Europe,” reflecting our commitment to our employees and the surrounding community.
At our Werthenstein BioPharma site in Schachen, we conduct cutting-edge research and develop new biological agents while supplying clinical trial products for global studies, ensuring the security and safety of our patients throughout the supply chain.
Apply online using the form below. Please note that only applications matching the job profile will be considered.