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Director QA Fill & Finish

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Job Description


Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the “Janssen Pharmaceutical Companies of Johnson & Johnson” trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices.
Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.

Director QA Fill & Finish


The Director QA Fill&Finish has a critical role in assuring that the Schaffhausen site maintains a strong global compliance profile and in enabling optimum operational efficiency. As a key member of the quality team, the incumbent will serve as a trusted business partner to the site quality team in ensuring the effective delivery of quality services across the organization while providing a transparent quality perspective to stakeholders.


Objectives and Responsibilities
• Lead the Fill / Finish Quality Assurance resources at the Schaffhausen site
• Ensure Quality standards are reliably maintained and comply with J&J global guidelines and regulatory expectations.
• Provide quality and compliance guidance and leadership to the related operational units.
• Ensure that effective systems, measures and reporting are in place for monitoring and controlling the related GMP activities.
• Responsibility for the performance and development of the Fill / Finish Quality Assurance associates.

Main duties/Additional duties/ sphere of authority
• Compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function.
• Ensure production and analytical batch records are thoroughly reviewed to ensure compliance with GMP guidelines and registration dossiers.
• Ensure deviations in the production and analytical processes as well as product quality complaints are thoroughly investigated, issues are mitigated, appropriate CAPAs are defined, implemented and monitored for effectiveness.
• Ensure quality trend are identified and responded to in a timely and effective manner.
• Ensure permanent inspection readiness state and act as lead in J&J internal and external regulatory inspections.
• Manage QA lead times to ensure a timely product disposition.
• Drive continuous improvement holistically in the department and for quality topics on the entire site.
• Review and approval of SOPs and WIs.
• Ensure sufficient and appropriately trained QA resources are deployed.
• Ensure performance reviews are conducted with all associates.
• Act as functional and disciplinary supervisor to all QA Fill / Finish associates.
• Budget (headcount, expenses, CAPEX) responsibility for the QA Fill / Finish department.
• Initiate quality escalations and lead escalation meetings.
• Get involve and / or drive sector and corporate initiatives.
• Member of the Quality Site Leadership Team.




Qualifications
  • A minimum of a Bachelor’s degree in science-based discipline is required. A Bachelor’s or higher degree in Life Sciences discipline, Pharmacy or Chemistry is preferred. 
  • Minimum 10 years of experience in Quality and/or Regulatory Compliance field, preferably in Pharmaceuticals.
  • Minimum 5 years demonstrated leadership and people development skills within a global supply chain function.
  • Strong knowledge of the applicable regulations and regulatory processes required.
  • Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations and proven success in implementing and maintaining cGMP compliance is required.
  • Strong background and knowledge of quality systems management (risk management, control strategy, product quality management, among others) is required.
  • Knowledge of aseptic operations and solid oral dosage manufacturing is considered an asset. 
  • Ability to work across organizational boundaries in a global matrix organization, through influence, negotiation and partnering for changes requiring buy-in from all stakeholders at all levels.
  • Strong decision making and problem solving competencies
  • Must be proficient in English (oral and written). Proficiency in German is preferred.
  • Must be proficient in the use of Microsoft Office (Word, Excel, PowerPoint and Outlook).


Primary Location
Switzerland-Schaffhausen-Schaffhausen-
Organization
Cilag AG (8562)
Job Function
Quality
Requisition ID
2005804608W