Lead QA Manager

Vor 2 Tagen

Visp, Schweiz TN Switzerland Vollzeit

Lead QA Manager - Process and Cleaning Validation

Location: VISP

Hybrid Working Model (3 days in the office, 2 days WFH)

Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers, improving the world through their ideas.

The role:

The site is growing for our Biologics organization. The Lead QA Manager operates in close cooperation with the Manufacturing Science and Technology (MSAT) and Production departments and with customers, ensuring that all manufacturing processes and cleaning processes for manufacturing equipment throughout their lifecycle are performed and validated in compliance with cGMP requirements and internal/external quality standards.

Key responsibilities:

  1. Defines the Process Validation strategy in conjunction with MSAT.
  2. Acts as a Quality and Compliance representative and is a key member of cross-functional technical project teams.
  3. Defines the Cleaning Validation strategy and process-specific cleaning validation activities in conjunction with MSAT.
  4. Coordinates Quality and Compliance objectives during different project phases regarding Process and Cleaning Validation activities.
  5. Supports and approves Quality Risk Analysis related to manufacturing processes and equipment cleaning (e.g., FMEA).
  6. Reviews and approves Process and Cleaning Validation related documents (plans, protocols, reports).
  7. Reviews and approves periodic reports related to the process and cleaning lifecycle (Continued Process Verification (CPV) / Annual Cleaning Review).
  8. Ensures accuracy of data detailed within process and cleaning validation reports.
  9. Supports specific projects in process and cleaning validation to develop further the quality standard.
  10. Reviews and approves Process and Cleaning Validation related to Deviation, OOS Investigations, Change Requests, and CAPAs.
  11. Supports internal, stakeholder, and regulatory audits and inspections.

Experience and skills:

  1. BSc, MSc, or PhD in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering, or related field.
  2. 5+ years experience in biopharmaceutical manufacturing, preferably in a QA/qualification/validation/MSAT function with a strong background in cGMPs.
  3. Good communication skills and ability to interact with various interfaces within the organization, customer representatives, and regulatory agencies (Swissmedic, FDA, etc.).
  4. Fluency in English; German would be an advantage.

Lonza’s products and services positively impact millions of people. We respect and protect our people and our environment, achieving success ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences, making a meaningful difference.

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