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Quality BP APIs & Strategic Materials

Bayer AG (3-PROD)
place
Basel

1W

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Quality BP APIs & Strategic Materials

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change

Quality BP APIs & Strategic Materials

Job Tasks & Responsibilities:

  • Direct the activities of Quality API & SRM team worldwide (5-7 Quality Managers)
  • Major goal is to assure and monitor the quality and compliance vs current regulations in force and Bayer standards of the suppliers and materials provided to Bayer
  • Lead Supplier Selection Process from Quality (Q) perspective for the Consumer Health Division and Coordinate the input from the team in order to support Business in relevant decision boards and platforms in liaison to Q BP Network & Portfolio Lifecycle Management function
  • Define requirements and provide guidance related to Supplier Qualification from Quality perspective for the Consumer Health Division. Manage the process of Supplier Qualification activities as a prerequisite for Supplier approval. Accountable and responsible for review & approval of Quality assessment for new suppliers which are proposed for new Sourcing decisions
  • Define and implement Supplier and Product Monitoring & Management from QA point of view
  • Establish Q API & SRM Quality Standards and Metrics: Process creation, review, alignment and continuous improvement. Steer, from a QA standpoint, Suppliers and Product Governance model including supplier evaluation and product / processes risk assessments
  • Act as main representative of the team in front of main API & SRM stakeholders (PRO, Supply Chain) for strategic initiatives and projects
  • Collaborate with Q EM & Supply Head on strategy definition to ensure deployment execution within Quality API & SRM and represent CH in Cross-divisional Q API & SRM topics. Represent CH Division in regards to API & SRM Supplier management
  • Lead operational excellence and continuous improvement initiatives, PSS, product and process robustness
  • Drive digitalization and IT initiatives to ensure its implementation within Q API & SRM team. to gain efficiencies
  • Ensure proper follow up of needed activities in NPS and link to R&D
  • Drive compliance, together with team members by ensuring that any relevant regulation is implemented in time at Suppliers and Audit & Inspections findings are properly followed up. Ensures that all processes within API & SRM area of responsibility are established. Drafts/Reviews Global procedures whenever requested
  • Assures coordination with suppliers and sites (internal and external) and provides expert feedback for Issue management on API/ Excipients/ Herbals/ Packaging materials
  • Supports sites (internal and external) with regards to any Quality topics related to supplier qualification and evaluation, Risk assessments, among others. Supports the site network (internal and external) by establishing Divisional Quality Agreements whenever the sites are unable to negotiate them
  • Gatekeeper for identified issues with QA and regulatory impact regarding ingredients (e.g. SWATs)
  • Provide with required support to API & SRM Quality Managers: Coordination of actions in PQSC and Critical Issues, Supplier Complaint trending review, link to business protection from API & SRM. Training of suppliers and Quality Managers on boarding training
  • Act as back up of Q EM Supply & Strategy Head

Job Requirements:

  • The incumbent should have a degree in the life science (pharmacist, chemist or chemical engineering) with at least 10 years of experience in pharmaceutical quality assurance / management or equivalent education / experience
  • Experience in international quality management is essential for this function as well as excellent knowledge of international and regional cGMP-, ICH- requirements, Cosmetic and Dietary supplements requirements and other quality assurance guidelines
  • Minimum 5 years of solid Team leadership experience, coaching and developing a dynamic organization with the ability to work effectively in different teams, including in non-hierarchical matrix organization
  • Transformational leader with demonstrated learning agility specially in change and people
  • Green or Black Belt Lean Six Sigma certification is a plus
  • Agile learner with ability to anticipate needs and be pro-active is required 
  • Cross-functional team player with excellent communication and negotiation skills for international interactions is required
  • Demonstrate workload prioritization and time management is an advantage
  • Strong flexibility to adapt to different business cultures is an advantage
  • Experience working with API and Raw Materials suppliers is a plus
  • Strong analytical and problem-solving skills is an advantage
  • Ability to travel up to 20% of time, across the globe is required
  • Fluent in English is a must, additional languages such as German are beneficial

Location:

Division:

Consumer Health

Reference Code:

349821