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Careers at ThermoFisher Scientific

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Job ID :
44134BR
Location :
United Kingdom - Horsham
:
Job Description

About ThermoFisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com .

The BioPharma Services Division (BSD) of Thermo Fisher Scientific Inc. is the world leader in expediting drug research and delivering patient hope. A highly successful and high growth division, BioPharma Services employs 3,000 dedicated individuals globally providing world class pharmaceutical and biopharmaceutical solutions including clinical trial packaging, labeling, supply chain, logistics and laboratory testing.

Job Description


Job Title: Senior Manager, QA Compliance
Reports To: Director, Quality
Group/Division: BSD
Career Band: 8
Job Track: Management
Position Location: Horsham
Number of Direct Reports: 3

Position Summary:


Reporting directly to the Director of Quality, the jobholder is responsible for providing effective leadership for all aspects of Compliance and Quality Systems Quality Assurance relating to Fisher Clinical Services UK and ensuring that Quality Assurance is integral to the business strategy (3-Year outlook) and ‘fit for purpose’ in delivering on Business Goals

The role will be responsible for assuring compliance with all relevant GXPs under the framework of a best in class quality system. In addition the job holder is a key individual in strategic planning for FCS globally, including participation in acquisition/partnerships/ joint ventures as part of a due diligence team.

Key Responsibilities:

  • To provide leadership, enablement and direction to the Compliance Quality Assurance team to ensure that the quality system is fulfilling the regulatory and business needs for the FCS UK site.
  • To ensure absorption into the quality system of any future acquisitions in support of the global distribution business for FCS
  • To work via business development and Project Management to ensure that the FCS Quality Assurance function is engaged with customer to ensure that Quality is a service differentiation for FCS globally.
  • Provision of quality consultancy advice to sponsors planning clinical programmes in Europe – e.g. small /medium Biopharma companies in the USA.
  • Ensure the next generation of GXP systems are fully compliant with the relevant legislation.
  • Quality performance monitoring and liaison to resolve quality issues.
  • Take part in Senior management meetings as required and to provide relevant information to the meeting including project updates and Key Performance Indicators to GM, Finance and Senior Management team.
  • Working with the direct reports to ensure all Fisher activities come together in a timely manner – this could include supporting direct reports to overcome barriers to service delivery.
  • To undertake additional duties as directed and agreed with the Director, Quality.

Minimum Requirements/Qualifications:

  • Extensive knowledge of GMP/GDP environments.
  • Knowledge of the Clinical Manufacturing and QA compliance/Quality Systems process globally
  • Eligibility to become a Qualified Person would be desirable for this position
  • Commercial acumen.
  • Teamwork especially in a matrix management organisation. Ability to influence across functions across Fisher sites and across companies to achieve objectives.
  • Proven networking skills – must be able to network internally and externally with client organisations and other service providers
  • Significant experience gained at a senior level within a pharmaceutical environment
  • Process analysis skill suitable to collect/analyse data leading to proposed process improvement with quantifiable business benefit
  • Flexible and adaptable, with strong customer management skills. Must be highly responsive whilst maintaining strategic direction. Needs to be comfortable with ambiguity.
  • Ability to recruit and manage staff to achieve business objectives. Able to prioritise teams workload and to ensure others meet timescales.
  • Able to analyse problems and define solutions.
  • Able to work under pressure and to support others within the team.
  • Good communication skills both internally and externally. Ability to understand the clients requirements and to be able to devise and articulate the most appropriate solutions.
  • Creativity – ability to be confident and convincing at highest level within the client organizations

Non-Negotiable Hiring Criteria:

  • Degree Level or Equivalent in relevant subject
  • Professional Qualifications within the quality arena
  • Business management training – especially in business processes analysis/process improvement




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