Posted: 17 February 2022

Manager Quality Assurance Operations – Thermo Fisher Scientific

Location: Groningen, The Netherlands
Hours: 40

Purpose of the job

Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by FDA, EMEA, ICH, and PIC/s. To assure compliance, quality and manufacturing systems are defined, implemented, practised, maintained and matured. The Quality Affairs Department is responsible for the development, implementation, updating, auditing and reporting on the status of the Quality Systems of Thermo Fisher Scientific Groningen, Quality Assurance, Quality Control tasks in relation to the manufacturing operations and batch disposition
decisions. The Quality Operations department, under direction from the site Quality Affairs Director, oversees the direct engagements of the site Quality department with the biopharmaceutical manufacturing process (exclusive of Quality Control testing)

Job and position context

The site is a multiproduct and multi-client site that provides full-spectrum biopharmaceutical manufacturing services (i.e. development, clinical trials, process performance qualification and commercial manufacturing) in the production of bulk
Active Pharmaceutical Ingredient (API)/Bulk Drug Substance (BDS) via mammalian cell culture. This facility complies with all rules and regulations of current Good Manufacturing Practice (cGMP) set by individual jurisdiction health and welfare
ministries.
Scientific: Focus on documentation, to ensure compliance of products with international quality requirements (cGMP) and in line with the customer-specific requirements and expectations. Implementation and/or development of analytical
methods/techniques/strategies. Development of own knowledge related to own activities. The Quality Operations Manager has knowledge in his/her field of expertise.
Organizational: The Quality Operations Manager needs good communication and leadership skills and has to work in close collaboration with other colleagues. Internal and external networking: Contact with other QA Officers within Thermo
Fisher Scientific and external specialists for benchmarking and development. Contact with project management, QA compliance managers, Quality Control Line managers, QC technicians and QC supervisors/lab heads. Quality and EH&S: By definition, the Quality Operations Manager works according to EH&S and GMP guidelines.

Accountability and responsibility

  • Oversee and provide the leadership to the Quality Operations department, responsible for the execution of all related operational Quality assurance tasks applicable;
  • Responsible for Quality Assurance oversight of the manufacturing operations at the Thermo Fisher Scientific Groningen site to ensure the corresponding GMP compliance in every phase according to regulatory expectations. This
    includes:
    • Manufacturing Quality Assurance (Shop Floor Quality)
    Clinical Quality Assurance Support;
    • Product Disposition;
    • cGMP Document Review;
    • Raw material and intermediate release;
    • Investigations;
    • Risk Management.
    • Management Responsibilities:
    • Leadership in developing, implementing and maturing of related Quality
    Systems;
    • Management in support of multi-shift manufacturing operations;
    • Direct engagement with regulatory inspections including preparation,
    management & response development;
    • Training of Quality and Manufacturing personnel in the principles and
    application of cGMP pertaining to work that supports cGMP lot disposition
    among others;
    • Hiring, coaching and mentoring professional Quality staff

Authorities

Interact with the national and international ministry of Health authorities and regulatory inspections

The complexity of the job

The Thermo Fisher Scientific site in Groningen manufactures many products for several stages of clinical trials and for commercial use. The cGMP systems in use on the site must reflect the dynamic, constantly changing, the regulatory environment for biopharmaceutical products

Knowledge and educational level

  • Master degree in Biochemistry, Pharmacy or Biotechnology (or equivalent) is preferred;
  • Deep understanding of the regulatory/Quality responsibilities in bulk active pharmaceutical ingredient (API) batch disposition;
  • Subject Matter expertise in several elements of pharmaceutical manufacturing;
  • Extensive organizational/personnel management capabilities;
  • Experience dealing directly with both regulatory agency personnel as well as client representatives;
  • Strong written, verbal and presentation skills.

Required level of experiences

  • Experience dealing directly with both regulatory agency personnel as well as client representatives;
  • Experience in leading teams;
  • Experience in operational GMP in a pharmaceutical manufacturing
  • Environment including batch disposition;
  • Experience in working in a multidisciplinary environment and customer relationship management.

Competences

  • Decisiveness;
  • Planning and organization;
  • Problem analysis;
  • Initiative;
  • Sound Judgement;
  • Customer satisfaction;
  • Result oriented;
  • People manager and team player.

For more information about this vacancy, contact Managing Partner Albert Peters +31 6 28209882

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