Senior Quality Control Manager

4 weeks ago


Basingstoke, Hampshire, United Kingdom Thermo Fisher Scientific Full time

Job Summary:

The Senior Quality Control Manager will be responsible for leading the Quality Control laboratory team to ensure the highest level of quality and compliance with regulatory requirements. This includes developing and implementing quality control procedures, managing laboratory operations, and ensuring that all testing is carried out in accordance with product specifications and external quality control requirements.

Key Responsibilities:

  • Develop and implement quality control procedures to ensure compliance with regulatory requirements.
  • Manage laboratory operations, including coordinating work scheduling, planning, and general administration.
  • Ensure that all testing is carried out in accordance with product specifications and external quality control requirements.
  • Monitor, record, analyze, and report on activities, trends, results, and recommendations relating to Quality Control and department activities.
  • Be responsible for the review and approval of all testing, reports, deviations, and department Standard Operating Procedures (SOP) to support the QC department.
  • Maintain up-to-date knowledge of ISO, BS, and other relevant standards and ensure their application in laboratory procedures.
  • Drive a culture of continuous improvement within the laboratory by ensuring process performance and compliance improvement programs for the Microbiology Laboratory are identified and implemented.
  • Ensure non-conformances impacting Microbiology Laboratory processes are initiated and investigated in a timely manner, collaboratively with the Manufacturing sciences team, to minimize impact to the customer.
  • Provide microbiological technical expertise, trouble-shooting, training, and support to the laboratory team in the testing of all product ranges.
  • Responsibility for the release of product to external and internal acceptance criteria.
  • Maintain a safe laboratory work environment and follow all laboratory safety requirements, working with the Site and divisional health and safety team to ensure compliance with appropriate regulations.
  • Drive collaborative relationships between internal collaborator departments and Quality with the overall focus of improving customer satisfaction.
  • Manage the personnel and fiscal budgets.
  • Supports, adopts, and promotes the Thermo Fisher 4 I values – Integrity, Intensity, Innovation, and Involvement.

Requirements:

  • Bachelor's degree required in microbiology or sciences with experience in a medical device, pharmaceutical, or clinical Quality Control.
  • Experience leading a team of scientists.
  • Experience running BSL2 laboratory, BSL3 experience preferred.
  • Experience with medical device, GMP, EU Regulation, or ISO 13485, 11133, and Guide 34.
  • Proven solid understanding of quality and scientific principles.
  • Laboratory Safety Experience.
  • Ability to prioritize multiple tasks/functions optimally in a global organization.
  • Proven track record to work effectively as a member of a cross-functional team.

Preferred Qualifications:

  • SAP Quality Module experience.
  • Strong leadership skills with the ability to challenge, influence, and build consensus.
  • Excellent oral and written communication skills.


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