Head of Global Quality Assurance

10 hours ago

Slough, Slough, United Kingdom Indivior Full time
Job Title: Head, Global Quality GxP Audit Programs

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.
  • Maintain risk-based strategic audit plans covering GxP audit programs for internal and external processes.
  • Generate and execute annual internal and external GxP audit plans. Internal audit plan to include at least critical GxP processes and external audit plan to include key GxP supplier partners.

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.
  • Good communication skills and able to debate and negotiate with personnel from all supply functions personnel.
  • Well-developed influencing skills.
  • Diplomatic and tactful in difficult situations.
  • Highly motivated and confident. Organised and able to deliver concise written or oral summaries to senior management.
  • Able to lead on improvement plans within factory, requires a good manufacturing knowledge and an understanding of factory/quality management system.
  • Able to train and coach others in risk assessment and auditing techniques.
  • Persistent and driven to achieve a final solution. A complete finisher.
  • Expert working knowledge of regulations that impact Indivior globally.
  • Strong planning and organisation skills.
  • Auditing skills, appropriate qualifications in auditing a must.

Preferred Qualifications:

  • 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.
  • Executive presence for giving presentations and updates is helpful.
  • Influencing skills in areas with no direct reporting authority.
  • Motivated by delivering high quality patient treatments in the arena of addiction.
  • Proficient in English. However, fluency in other languages is advantageous.

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

Indivior's Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

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