Head, Global Quality GxP Audit Programs
Reports To: VP, Quality Management
Location: United Kingdom or United States Indivior Based Offices
Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear.
POSITION SUMMARY:
The Head, Global Quality GxP Audit Programs is a critical part of the global quality organization, with significant support to and partnership with all GxP Functions within Indivior. As a member of the Global Quality Leadership Team (QLT), this position reports directly to the Vice President, Quality Management.
The position is a strategic and tactical, hands-on leadership role providing oversight, planning, execution, and maintenance of the various GxP and REMS (Risk Evaluation and Mitigation Strategies) audit programs within R&D and Commercial environments.
ESSENTIAL FUNCTIONS:
- Assesses the performance of the Pharmaceutical Quality System (PQS) through the identification of nonconformances and areas of positive performance during execution of the audit programs.
- Works across functional boundaries modeling the Indivior Guiding Principles to ensure operational alignment and driving continuous improvement.
- Liaison to the operations by identifying potential compliance gaps and partnering with the business to identify and drive best practices for sustainable solutions.
- Serves as a subject matter expert on international product and process quality regulations, standards, guidance documents, and identified industry best practices.
MINIMUM QUALIFICATIONS:
Education: Bachelor of Science degree in a life science or engineering discipline. Postgraduate degree is preferred.
Experience: Minimum 15+ years with a proven track record in pharmaceutical, med device, or biopharma.
COMPETENCIES/CONDUCT:
- Good communication skills and able to debate and negotiate with personnel from all supply functions.
- Well-developed influencing skills.
- Highly motivated and confident, organized, and able to deliver concise written or oral summaries to senior management.
PREFERRED QUALIFICATIONS:
- Strong interpersonal and communication skills.
- Motivated by delivering high-quality patient treatments in the arena of addiction.
BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits.
EQUAL EMPLOYMENT OPPORTUNITY:
EOE/Minorities/Females/Vet/Disabled
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