Head of Quality Assurance
4 weeks ago
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 lead our Global Quality GxP Audit Programs.
Job Summary:The Head, Global Quality GxP Audit Programs will be responsible for overseeing the development and implementation of audit programs to ensure compliance with international product and process quality regulations, standards, and industry best practices. This strategic and tactical leadership role will provide oversight, planning, execution, and maintenance of GxP and REMS audit programs.
Key Responsibilities:- 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.
- Develop and lead the Global Quality GxP Audit Program Team to ensure roles and responsibilities are clearly aligned, personnel development, and succession planning.
- Maintain risk-based audit plans covering the PQS for commercial and R&D activities.
- Generate and execute annual internal audit programs for Indivior GxP Functions and third-party service providers.
- Bachelor of Science degree in a life science or engineering discipline. Post graduate degree is preferred.
- Minimum 15+ years with a proven track record in pharmaceutical, medical device, or biopharma.
- Auditing skills, appropriate qualifications in auditing a must.
- Proficient in English; fluency in other languages is advantageous.
- 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.
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Slough, Slough, United Kingdom Indivior Full timeJob Title: Head, Global Quality GxP Audit ProgramsJob Summary:The Head, Global Quality GxP Audit Programs is a critical role within the global quality organization, responsible for overseeing the planning, execution, and maintenance of GxP and REMS audit programs across R&D and Commercial environments. This position reports directly to the Vice President,...
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