Sharon Shutler

Sharon is a senior professional with over 30 years’ experience in the life sciences sector. She has worked with many companies ranging from start-ups to global pharma (in healthcare settings, biotechnology, speciality (bio)pharmaceuticals, sterile manufacturing, and diagnostic medical devices).

She has expertise in quality and compliance, auditing, the implementation of risk-based quality management systems, GxP validation (including computerized systems), technical writing, mentoring and training.

Sharon is a Chartered Quality Professional, a Fellow of the Chartered Quality Institute and an IRCA-certificated Principal Pharmaceutical Auditor. She is also a member of the Chartered Quality Institute’s Standards Panel and is a contributor to the review and development of ISO standards relevant for the life sciences industry.

Sharon is originally from Wales in the UK and currently lives in France near the borders with Switzerland and Germany.

The services Sharon can offer include the following, in both supportive and leadership roles:

  • Design, implementation and management of strategic, risk-based quality management systems based on pharmaceutical legislation, guidelines, industry best practice and relevant ISO standards
  • Management of remote and on-site audit programmes to ISO 19011
  • International pharmaceutical auditing (over 120 on-site audits of sterile medicinal product & API manufacturers, equipment suppliers, contract manufacturers, contract analytical laboratories, software vendors, wholesale dealers & distributors)
  • Preparation for, facilitation of, and follow-up after regulatory inspections (FDA, MHRA, Health Canada, Danish Medicines Agency, Australian Therapeutic Goods Administration)
  • Validation of GxP computerized systems, laboratory methods, sterile pharmaceutical manufacturing processes, equipment, clean room facilities & utilities
  • Mentoring trainee internal and supplier auditors and pharmaceutical quality professionals
  • Design and delivery of training courses including an introduction to pharmaceutical compliance and GMP refresher training
  • Technical assessment of certified pharmaceutical lead auditor training courses
  • Review of completed examination papers for professional qualifications (e.g. Diploma in Quality Management)
  • Preparation of technical / quality agreements between Contract Givers and Contract Acceptors
  • Compliance of serialization & product tracking (SPT) and ongoing process verification (OPV) processes
  • In-depth knowledge of computerised system lifecycle documentation based on GAMP 5 & AGILE methodologies for both GxP critical and non-GxP software solutions
  • Mentoring and continuing professional development
  • Implementation of corporate social responsibility (CSR) programmes
  • Interviewing applicants for quality and technical roles
  • Authorship of compliance-related publications (including supply chain risk management and impact of artificial intelligence on quality management)

If you would like to speak to Sharon you can contact

Free services supported by paid for services.  If you or any of your contacts are considering engaging a recruiter, consultant or trainer we will welcome the opportunity to be considered.