QA Responsible Person

The Life Science Career Network

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Job Title: QA Responsible Person (RP) / Commercial Quality Assurance Head

Location:
Visp, Switzerland

Duration:
Permanent contract (Onsite, Monday-Friday)

Role and Responsibilities:

The Fachlich verantwortliche Person (FvP)
ensures all business is conducted in compliance with Swiss medicinal product law and company policies. By law, the RP is directly responsible for the technical supervision of the operation, safety, efficacy, and quality of medicines, ensuring proper handling, importing, and wholesaling in accordance with Good Distribution Practice (GDP).

Your responsibilities will include:

• Act as the FvP for import and wholesaling activities in accordance with the Swiss Therapeutic Products Act (HMG) and related regulations and technical interpretations (e.g., I-SMI.TI.17). The RP has the authority to issue directives within their scope of responsibility.
• Supervise all business operations to ensure appropriate wholesaling activities.
• Secure and maintain all necessary licenses for the company`s Health's business operations.
• Ensure that a Quality Management System (QMS) is established, implemented, and maintained with clear work instructions, procedures, and protocols for GMP and GDP-related processes.
• Ensure that medicinal products are supplied in strict compliance with Good Distribution Practice (GDP).
• Collaborate with stakeholders across the company to understand processes outside of QA to determine the best path forward.
• Verify that manufacturers of imported pharmaceutical products hold a valid GMP manufacturing license.
• Ensure the traceability of all purchases and sales of pharmaceutical products and record the necessary information.
• Confirm that documentation proving the quality of traded batches of drug substance, intermediate drug product, and bulk product is complete.
• Independently decide on distribution stops and batch recalls when necessary.
• Manage quality and compliance risks.
• Approve all SOPs and other controlled documents related to the company`s Health's licensed activities.
• Act as the primary contact for and approve all Technical/Quality Agreements related to the supply, transportation, and wholesale of medicinal products marketed by company`s Health.
• Provide quality oversight and conduct audits of external service providers.
• Manage Health Authority Inspections and Corporate Audits.
• Manage all product recalls and quality complaints.
• Report quality issues to Swiss Medic according to requirements and within established deadlines.
• Address quality issues with the responsible Supplier/Manufacturing site.
• Stay up-to-date with Swiss regulatory requirements, authority organizations, processes, and the overall environment.
• Ensure awareness and implementation of applicable regulations and disseminate this information to relevant internal and external stakeholders.
• Act as the primary contact for all quality issues for Swiss Medic, the Cantonal Health Authority, and Third-Party Manufacturers.
• Plan and perform internal audits.
• Ensure that Site Quality Compliance Metrics are reported periodically to the Site Management.
• Lead Management Reviews.
• Ensure that all employees involved in distribution activities receive a GDP refresher training at least once a year.
• Participate in a course, seminar, congress, or equivalent with a focus on GMP/GDP at least once a year to stay current with regulatory requirements and industry standards.
• Assess the education and experience of the Deputy FvP and delegate tasks as appropriate.

We are looking for someone with:

• Degree in Chemistry, Pharmacy, or Biology.
• 5+ years of experience exclusive in quality assurance, operations, or regulatory affairs
  . Supervisory or management experience is preferred.
• Strong
  knowledge of QA systems and GxP compliance requirements
  , including regulations and standards for devices, biologics, and pharmaceutical products.
• Excellent written and verbal communication skills in both English and German.
• Demonstrated ability to think strategically to meet or exceed compliance and business needs.
• Strong decision-making and negotiation skills.
• Excellent computer skills with knowledge of enterprise systems.
• As the FvP, you must have the necessary professional training and experience to be accepted for this role by the authorities
  .

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.