Associate Director Quality Assurance (m/f/d)

Position Overview

We are seeking an experienced professional to support clinical quality activities at our Wernerstein site, ensuring adherence to stringent Good Manufacturing Practice (GMP) standards. This role demands a strong commitment to compliance and the ability to drive quality initiatives across various projects, focusing on both regulatory requirements and operational excellence.

Key Responsibilities

• Manage and lead quality activities to ensure compliance with cGMPs and worldwide regulations.
• Provide compliance assessments and guidance to senior management regarding policy alignment with regulatory expectations.
• Stay updated on current GMP requirements and industry trends, influencing client areas with insights on regulations.
• Oversee departmental SOPs, ensuring they are current and reflective of regulatory changes.
• Review and approve GMP documentation related to regulatory filings and clinical supplies, maintaining compliance with requirements.
• Coordinate and facilitate regulatory agency inspections, preparing reports and response drafting as necessary.
• Advise on GMP compliance in the design of facilities and equipment selection, and SOP preparation.
• Represent quality interests in internal or external manufacturing programs, involving compliance oversight and record approvals.
• Develop and maintain quality systems and policies for the Development Quality department.
• Actively participate in audit and inspection programs, evaluating compliance deficiencies and resolving findings.
• Notify management of compliance issues and performance trends for supported areas.

Essential Qualifications

• A Master’s Degree in Engineering, Sciences, or a related field with a minimum of five years’ experience in a regulated industry such as pharmaceuticals or biotech.
• In-depth knowledge of integrated manufacturing operations and prior experience in drug substance manufacturing.
• Proven experience in technical writing, including investigations and standard operating procedures.
• Familiarity with formal problem-solving techniques and a hands-on approach to issues.
• cGMP experience in sterile or vaccine environments is highly valued.
• Fluency in English and conversational German is preferred.

Preferred Skills and Competencies

• Experience leading Health Authority Inspections and participation in due diligence projects.
• Strong capabilities in project management, ensuring effective multitasking and initiatives accomplishment.
• A proactive approach to upskilling team members, fostering a knowledge-sharing environment.

About Us

We are a leading biopharmaceutical company with over 1,000 employees across three sites in Switzerland. Our commitment to quality and community involvement sets us apart as a certified “Top Employer Switzerland” and “Top Employer Europe.” Our Werthenstein BioPharma site specializes in the research, development, and supply of clinical trial products, ensuring the highest standards for patient safety and product integrity.

Join us in our mission to innovate and improve healthcare through advanced biological agents and therapies for various therapeutic areas.