Senior Manager, Quality Country GxP Compliance

Vor 2 Tagen

Baar, Schweiz AstraZeneca Vollzeit

Senior Manager, Quality Country GxP Compliance (Alpine) & Responsible Person (Switzerland)

Reports to: Associate Director, CENE Regulatory Affairs

Location: Baar, Switzerland

Introduction to Role:

This position is primarily focused on fulfilling the technical responsibilities of the Swiss Responsible Person (RP) for Alexion Pharma GmbH's Swiss Establishment License, as required by Swiss Law SR 812.212.1, Medicinal Products Licensing Ordinance (MPLO). The function holder also maintains the quality management system (QMS) for all GMP/GDP activities for Switzerland.

The Swiss RP should be capable of fulfilling their responsibility, understanding the Swiss GMP/GDP requirements, and meeting regulatory compliance. To ensure compliance with the legal requirements, the direct supervision of the company by the RP must be guaranteed at any time. In addition, the Senior Manager, Quality Country GxP Compliance (Alpine) acts as the quality lead for Switzerland and Austria (Alpine Region).

Detailed accountabilities:

Direct technical supervision of the company’s operations to ensure the safe trading of medicinal products in Switzerland. In particular, the position holder is authorized to issue directives and instructions within the scope of GDP and GMP to other personnel in the company. Responsibilities include:

  • Operating the Swiss Establishment License for import with market release and ensuring the traceability of medicinal product traded within Switzerland.
  • Assurance that each batch of medicinal product for the Swiss market is in compliance with the specifications in the Swiss marketing authorization with respect to its composition, manufacturing process, specifications, and quality requirements (including information on additional sampling, inspections, or controls due to possible deviations).
  • Ensuring medicinal products are supplied in accordance with the rules of GMP (good manufacturing practice) and GDP (good distribution practice) in Switzerland.
  • Decision on the release or non-release of a batch for the Swiss market, independently of the company management, as per MPLO art13.
  • Archiving general and batch-specific documents concerning the manufacture and testing of medicinal products released onto the Swiss market, particularly the manufacturer's batch certificate.
  • Interaction with Swissmedic for quality-related topics.

Management of the local Swiss Quality Management System (QMS), including:

  • Implementing, supervising and maintaining the local QMS for all GMP/GDP activities for Switzerland.
  • Setting-up and updating quality agreements (QAGs), in collaboration with Alexion Global QA, for delegated or subcontracted activities.
  • Maintaining the Swiss Site Master File.
  • Evaluating the global product quality review (PQR) to verify that the product and processes remain in compliance with the Swiss marketing authorization.

Product quality complaints, quality defects and product recalls:

  • Product returns
  • Deviation, change control and CAPA management

Crucial Skills/Experience:

  • Legally required education: qualifications in natural sciences (university or equivalent)
  • Pharmaceutical or biological-natural sciences' knowledge.
  • Experience in the manufacturing of medicinal products or ATMP (GMP), or the wholesale of medicinal products (GDP);
  • Experience in quality assurance work within a company/institution that manufactures medicinal products or transplant products.
  • Proficiency in both German and English language

Why join us?

At Alexion, AstraZeneca Rare Disease, we push the boundaries of science to transform complex biology into life-changing medicines. Our dedication to patients drives us to innovate continuously. With a rapidly growing portfolio, we offer an entrepreneurial spirit combined with the resources of a global biopharma. Join us to make a meaningful impact on patients' lives while growing your career in an encouraging environment that values diversity, innovation, and connection.

Ready to make a difference? Apply now

Date Posted: 21-Jan-2025

Closing Date:

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

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