Head, Global Quality Assurance and Compliance

2 days ago

Slough, Slough, United Kingdom Indivior Full time
Job Summary

The Head, Global Quality Assurance and Compliance will be a critical member of the global quality organization, providing strategic and tactical leadership to support the company's quality initiatives. This role will report directly to the Vice President, Quality Management.

Key Responsibilities
  • Develop and implement risk-based audit plans to ensure compliance with regulatory requirements and company policies.
  • Lead the Global Quality Assurance and Compliance team to ensure the effective execution of audit programs and the identification of nonconformances and areas for improvement.
  • Collaborate with cross-functional teams to drive continuous improvement and ensure operational alignment.
  • Serve as a subject matter expert on international product and process quality regulations, standards, and guidance documents.
  • Develop and lead the Global Quality Assurance and Compliance team to ensure roles and responsibilities are clearly aligned, and personnel are developed and trained.
  • Ensure that all Indivior facilities and functions operate in a state of quality compliance to ensure all products manufactured are safe, efficacious, and effective for intended patient use.
  • 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, including critical GxP processes and key GxP supplier partners.
  • Participate in management reviews, providing clear visibility of risks and risk reduction actions, including independent tracking and escalation of commitments.
  • Generate audit compliance and trending metrics and reporting to respective lead teams.
  • Assist with inspection readiness efforts, coordinate follow-ups, and ensure responses after external inspections.
Requirements
  • Bachelor of Science degree in a life science or engineering discipline. Postgraduate degree is preferred.
  • Minimum 15+ years of experience in pharmaceutical, medical device, or biopharma, with a proven track record in quality assurance and compliance.
  • Strong communication and influencing skills, with the ability to debate and negotiate with personnel from all supply functions.
  • Well-developed influencing skills, diplomatic, and tactful in difficult situations.
  • Highly motivated and confident, organized, and able to deliver concise written or oral summaries to senior management.
  • Able to lead on improvement plans within the factory, requiring a good manufacturing knowledge and an understanding of factory/quality management systems.
  • 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 organization skills.
  • Auditing skills, appropriate qualifications in auditing a must.
Preferred Qualifications
  • Strong interpersonal and communication skills, with the ability to communicate clearly to all levels of the business.
  • 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.

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