6 дней назад
Compliance Auditor (cGMP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Compliance Auditor (cGMP) (Biologics, Cell and Gene Therapies, Sterile Products, APIs): Designing, planning, and executing high-impact corporate cGMP audits across global manufacturing sites with an accent on regulatory compliance, supplier quality, and inspection readiness. Focus on assessing compliance risks, advising sites on remediation and regulatory inspections, and mentoring auditors during significant international travel.
Location: Remote from Manchester, UK; requires significant international travel across global manufacturing sites and operational facilities, approximately 50–60% of the time.
Company
is a global life sciences company with more than 30 sites across five continents, manufacturing medicines and supporting customers’ breakthrough therapies.
What you will do
- Design, plan, and execute corporate cGMP compliance audits across biologics, cell and gene therapies, sterile products, APIs, medical devices, and hardware/software operations.
- Advise manufacturing sites on regulatory compliance, risk assessment, remediation actions, and health authority inspection preparation.
- Provide GMP compliance expertise, best-practice guidance, and continuous inspection-readiness support.
- Perform supplier quality assessments and audits, acting as the global Single Point of Contact for assigned suppliers.
- Monitor compliance risks across business units and support quality improvement initiatives.
- Mentor and coach auditors while providing senior compliance guidance.
Requirements
- Previous experience as a Health Authority Inspector with the MHRA or HPRA, conducting cGMP inspections.
- At least 10 years of cGMP quality assurance or auditing experience.
- Experience leading global corporate cGMP audits across diverse manufacturing sites.
- Experience advising on regulatory compliance, risk assessment, remediation strategies, and health authority inspections.
- Experience with supplier assessments and global supplier relationship ownership.
- MSc or equivalent degree in Chemistry, Biochemistry, Pharmacy, or a related field.
Culture & Benefits
- Agile career opportunities and a dynamic working culture.
- Inclusive and ethical workplace.
- Local benefits tailored to the employment location.
- Access to global benefits.
- International collaboration across globally connected teams.
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