Quality Operations Senior Specialist (LOA008170)

The Role
This Pharmaceutical company is looking to recruit aQuality Operations Senior Specialist, Drug Product, EMEA and Asia Pacificon a 12 month fixed-term contract (maternity cover)to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing.

Key Duties and Responsibilities:

• Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
• Actively support the Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products.
• Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.
• Provide the requisite quality support to Global functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
• Coordinate quality metrics programs in relation to Third Party performance.
• Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
• Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
• Review the Annual Product Reviews submitted by the Third Party Manufacturers.
• Support the Global external auditing program by participation in audits of Third Parties as requested.
• Provide support to specified quality and technical projects as they arise.

• In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
• Ability to develop cross-functional and external working relationships
• Strong communication and presentation skills across all levels both internal and external.
• Proven analytical and problem solving skills.
• A BSc in a scientific discipline such as Chemistry or Microbiology
• Minimum 5 years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
• Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
• Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections
• Direct experience in interfacing with external manufacturers

• You will help patients in their fight against serious diseases
• You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package