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Senior Quality Manager

vor 2 Monaten


ValdeTravers District, Schweiz WuXi AppTec Vollzeit
Job Title: Senior Project Manager

This position plays a critical role in ensuring the quality and compliance of our pharmaceutical products at the Couvet site. As a member of the Quality Leadership Team, the successful candidate will collaborate with other team members to maintain and improve quality systems, ensuring timely resolution of any compliance issues.

The Senior Project Manager will serve as the main Quality representative and single point of contact for QA, Compliance, Quality Supplier, and Regulatory Affairs within the site's key projects teams. This includes acting as the point of contact with customers for quality topics, coordinating responses and notifications, and driving quality activities related to change controls, assessments, and regulatory compliance.

Key Responsibilities:

  • Conduct assessments of change controls for site-related projects and product life-cycle projects with relevant quality SMEs.
  • Act as the site interface with Global Regulatory (CMC & Affairs).
  • Support site Quality activities such as multi-site investigations, drive change controls upon requests, and ensure compliance to security policies and laws concerning health and security of workers.
  • Approval of documentations related to Suppliers/CSPs qualification and maintenance activities.

Requirements:

  • At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affairs in a pharmaceutical company or related industry.
  • Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related science.
  • Strong knowledge of global drug development processes, clinical trial data flow, and analytical/technology transfer to manufacturing/testing sites and product launches.
  • Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration.
  • Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation.
  • Ability to communicate effectively to management, functional groups, broader organization, and executives.
  • Excellent investigational and QA problem-solving skills.
  • Knowledge of most common office software and IT principles.

Company Overview: WuXi AppTec is a leading global pharmaceutical and biotechnology company that provides a comprehensive range of services and products to support the discovery, development, and manufacturing of pharmaceuticals and biologics.