Associate Director Quality Assurance (m/f/d)

Position Overview

This role involves supporting clinical quality activities at our Werthenstein site, ensuring compliance with Good Manufacturing Practice (GMP) requirements and clinical drug substance operations. The individual will be accountable for driving compliance-based programs and leading cross-functional projects aimed at enhancing quality systems and regulatory adherence.

Responsibilities

• Manage, execute, and lead quality activities to ensure GMP compliance and alignment with applicable regulations.
• Provide assessments on compliance status and risk posture to senior management, advising on policy and procedural alignment with regulatory expectations.
• Stay informed on current GMP requirements and industry trends, offering insights on proposed regulations and their impacts.
• Ensure departmental Standard Operating Procedures (SOPs) reflect current regulations and oversee their periodic updates.
• Handle the review and approval of GMP documentation for regulatory filings and ensure compliance with all relevant requirements.
• Coordinate and accompany regulatory agency inspections, leading the drafting of responses to any observation reports.
• Advise on GMP compliance regarding facility design, equipment selection, and quality-related practices.
• Act as Quality representative for internal and external manufacturing programs, overseeing related compliance activities.
• Manage resources efficiently while adhering to company policies and regulatory requirements.
• Develop and represent quality systems and policies for the Development Quality department.
• Participate in GMP audit programs and assess compliance impacts, collaborating with teams to resolve findings.
• Communicate compliance issues and performance trends to relevant management teams.

Preferred Skills and Competencies

• Experience with integrated automated operations and drug substance manufacturing.
• Participation in health authority inspections and fluency in English, with conversational skills in German considered advantageous.

Required Experience and Skills

• Experience in the pharmaceutical, biotech, or other regulated industries.
• Technical writing expertise, including investigations and SOPs.
• Ability to manage multiple investigations and projects within set deadlines.

Direct Involvement Opportunities

• Serve as Quality Local Lead for major companywide efficiency projects, such as automated IT systems implementation.
• Participate in quality management system redesigns to meet regulatory expectations.
• Engage in due diligence for asset integration and support decision-making processes.
• Contribute to upskilling less experienced staff in managing complex deviations and change controls.

Your Profile

• A Master’s Degree in Engineering, Sciences, or a related field, along with at least five years of relevant experience.
• Experience with formal problem-solving methods.
• Familiarity with cGMP in various pharmaceutical environments, understanding critical process parameters and equipment qualification principles.

About Us

We are a leading biopharmaceutical company, employing over 1,000 people across three sites in Switzerland, with our headquarters in Lucerne. Our diverse operational focus includes a global innovation and development hub in Zurich and a forensic laboratory in Schachen. We conduct numerous clinical trials annually, covering key therapeutic areas and maintaining a commitment to community health initiatives.

Recognized as a “Top Employer Switzerland” and “Top Employer Europe,” our company values employee commitment and community involvement. The Werthenstein BioPharma site specializes in cutting-edge research and development, supplying critical clinical trial products while ensuring product safety and security throughout the supply chain.