Senior Manager QA/RA Projects

This position is a safeguard and role model for the WuXi values and competencies.

Job Summary:

This position is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to support the site in the Company Regulatory Surveillance initiatives..

The position holder is responsible to ensure the proper support of the GMP stakeholder regarding the Product's Dossier and the Regulatory Surveillance.

As a member of the Quality Leadership Team, the position holder is collaborating with the other members of the QLT to ensure that on the Couvet site the Quality Systems are maintained and improved and that any cGMP compliance issues is duly addressed in a timely manner.

Experience / Education

• At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affair in a pharmaceutical company or other related industry.
• Bachelor's degree in Pharmacy, Chemistry, Microbiology or related science.

Knowledge / Skills / Abilities:

• Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
• Demonstrated experience in Regulatory strategies and tactics.
• Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site 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 transfer strategies to tactical execution.
• Excellent interpersonal, collaborative and organizational skills.
• Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.
• High credibility and reliability.
• Excellent investigational and QA problem solving skills.
• Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.
• Drives continuous improvement.
• Knowledge of most common office software and of IT-principles.

Essential Job Functions:

• Act as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR 812.212.1) and of the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for Couvet site.
• Act within the site's key projects teams as the main Quality representative and single point of contact for QA, Compliance, Quality Supplier, and Regulatory Affairs.
• Act as the point of contact with customer for quality topics, coordinates response / notification to the client related to quality topics
• Coordinate and drive quality activities related to:
  • Technology tech transfer,
  • Analytical tech transfer,
  • Raw materials introduction,
  • Supplier qualification,
  • Manufacturing specifications,
  • CMC dossier set up.
• Conduct assessment of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs).
• Support response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review, as well as review of regulatory authorities citation provided to other sites.
• Actively support site Quality activities such as :
  • multi sites investigations, drive change controls upon requests,
  • review of MBR and executed bact record related to NPI
  • Internal audits (as auditor)
  • health authority and client inspections
  • continuous improvement
• Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility
• Works closely with EHS to evaluate hazards and perform risk analysis
• Promotes safe practices and behaviors, verify that EHS rules are implemented and followed

Deputy role for and deputy activities

The position acts as deputy of the Site RP for the following quality processes activities under his/her responsibility.

• Release of batches as RP deputy
• Close out of Critical Complaints
• Approval of Complaints Extension Requests when an escalated approval is required.
• Approval of Investigation Reports/Notifications sent to Health Authorities related to Complaints
• Approval of Master Batch records
• Approval of documentations related to Suppliers/CSPs qualification and maintenance activities
• APR/PQR approval