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Head of Quality Assurance

2 months ago

Slough, Slough, United Kingdom Indivior Full time
Job Title: Head of Performance and Quality

Indivior is a global specialty pharmaceutical company dedicated to developing medicines to treat substance use disorders and serious mental illnesses. We are seeking a highly skilled and experienced professional to join our team as the Head of Performance and Quality.

Job Summary:

The Head of Performance and Quality will be responsible for leading the development and implementation of quality systems and processes to ensure compliance with regulatory requirements and industry best practices. This role will also oversee the planning, execution, and maintenance of GxP and REMS audit programs, providing audit and compliance guidance to ensure risk-based management within cGMP, PV, GCLP, and REMS program areas.

Key Responsibilities:
  • Develop and implement quality systems and processes to ensure compliance with regulatory requirements and industry best practices.
  • Lead the planning, execution, and maintenance of GxP and REMS audit programs.
  • Provide audit and compliance guidance to ensure risk-based management within cGMP, PV, GCLP, and REMS program areas.
  • Assess the performance of the Pharmaceutical Quality System (PQS) through the identification of nonconformances and areas of positive performance during execution of the audit programs.
  • Serve as a subject matter expert on international product and process quality regulations, standards, and identified industry best practices.
Requirements:
  • Bachelor of Science degree in a life science or engineering discipline. Post graduate degree is preferred.
  • Minimum 15+ years of experience in pharmaceutical, medical device, or biopharma with a proven track record in auditing and compliance.
  • Auditing skills and appropriate qualifications in auditing are a must.
  • Proficient in English; fluency in other languages is advantageous.
What We Offer:
  • 3 weeks' vacation plus floating holidays and sick leave.
  • 401(k) and Profit Sharing Plan.
  • Comprehensive Medical, Dental, Vision, Life, and Disability coverage.
  • Tuition reimbursement.

Indivior is an equal employment opportunity employer and welcomes applications from diverse candidates.