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Head of Global Quality Assurance
2 months ago
Job 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, Quality Management and is a key member of the Global Quality Leadership Team.
Key Responsibilities:
- Develop and execute risk-based audit plans covering the Pharmaceutical Quality System (PQS) for commercial and R&D activities, and for internal and external processes and key service providers.
- Generate and execute annual internal audit program for Indivior GxP Functions, suppliers, pre-wholesalers, freight forwarders, and 3rd party service providers that fall under GxP Regulations in all territories where Indivior has businesses, business partners and market product.
- Ensure alignment with Heads of Quality for proper planning and coordination of audit program.
- Lead the Global Quality GxP Audit Program Team to ensure roles and responsibilities are clearly aligned; development of personnel; establishment of succession planning; and, to ensure collaboration across all supported functions.
- Participate in various quality and business operational forums where applicable expertise is required.
Requirements:
- 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, med device or biopharma.
- Strong interpersonal and communication skills and ability to communicate clearly to all levels of the business, able to deliver concise written or oral summaries to senior management.
- Expert working knowledge of regulations that impact Indivior globally.
- Auditing skills, appropriate qualifications in auditing a must.
Benefits:
- 3 weeks' vacation plus floating holidays and sick leave
- 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
- U.S. Employee Stock Purchase Plan- 15% Discount
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health and Dependent Care Flex Spending options
- Adoption assistance
- Tuition reimbursement
- Leverage Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
- Gym, fitness facility and cell phone discounts
