Director GQA Manufacturing Compliance

St.-Prex, Switzerland

Posted: 10-Aug-2018

Ref#: CH-FER-0076 / R0007084


Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com :

In our Headquarter in St-Prex/Lausanne (Switzerland), we are looking for an:


Director GQA Manufacturing Compliance

Your mission

Carry out quality oversight of allocated Ferring manufacturing sites. Propose and ensure implementation of quality strategy that minimizes the risk of regulatory actions against Ferring. Promote and take ownership for influencing strategy decisions so that they meet the good practice standards established by the policies of the Organization, Health Authorities and current law.
Business Partner of the allocated VP of Product Supply Manufacturing division (either the division of Solids & Packaging Manufacturing or the division of Biopharma Manufacturing).

Main responsabilities:
  • Lead quality oversight and carry out quality initiatives at allocated Ferring Manufacturing Division (either the division of Solids & Packaging Manufacturing or the division of Biopharma Manufacturing) has direct responsibility for the Manufacturing Sites being in compliance with Ferring QMS and applicable health Authority regulations
  • Support sites during inspection readiness preparation and during health authority inspections
  • Lead response board for health authority and has responsibility for the cross -siteI function alignment at the manufacturing sites
  • Manage trouble shooting for critical deviations and follow up on corrective actions
  • Participate in the decision-making process of recalls
  • Lead the setting of TAs between HQ and manufacturing sites
  • Carry out, decide and lead the implementation of the GQA strategy of the Manufacturing division
  • Develop / Improve CSOPs
  • Ensure that GMP requirements and CSOPs are implemented and respected all over the manufacturing sites
  • Perform GMP management training
Performance Management
  • Define, decide and lead the implementation of the Quality KPI system and lead monitoring of improvement initiative at manufacturing sites Assess the quality risk in the area of responsibility and implement risk mitigation actions

People Management
  • Manage the site QA for allocated manufacturing sites Lead and motivate the manufacturing sites QA team and manufacturing compliance team in the achievement of their objectives. Decide with site managers on recruitment of Quality manager or QNQC positions on  allocated manufacturing sites
  • Perform performance appraisal of all allocated Site QA directors

Projects
  • Carry out and lead quality harmonization and alignment across the manufacturing sites
  • Work with R&D to provide a GQA input into transfer of projects from R&D to manufacturing sites
  • Provide support and technical expertise to Product Supply projects
  • Participate as permanent member to TOPS (Tech Ops Project Steering Committee)

Interface Management
  • Participate in the Business Control Board meetings, follow-up on actions, report back
  • Participate to Product Supply Manufacturing division meetings 

New Site Integration
  • Lead and ensure delivery of Integration Roadmap milestones for new sites

Regulatory Watch
  • Carry out regulatory watch and benchmarking
  • Represent Ferring Pharmaceuticals in professional associations
  • Act as opinion leader in the promotion of the Quality Management ideas, concepts and practices throughout

Required Eduction / Qualifications / Skills:
  • Doctorate or academic degree in natural or applied sciences (Pharmacy, Chemistry, Engineering, Biotechnology)
  • Strong Knowledge of Business Regulations (EU, FDA and others)
  • Minimum of 15 years work experience in quality assurance  and/or quality control in the pharmaceutical industry with both local and international working experience
  • Fluent in English (written and verbal communication)
  • Excellent interpersonal and communication skills
  • Business mindset
  • Project Management

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