Sr Director, Quality Operations, EMEA

4 weeks ago

Slough, United Kingdom Indivior PLC Full time
Sr Director, Quality Operations, EMEA & API Manufacturing

TITLE: Sr Director, Quality Operations, EMEA & API Manufacturing

Reports To: VP, Quality Management

Location: Slough, UK

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD.

POSITION SUMMARY:

The Sr. Director of Quality Operations EMEA & API Manufacturing is a critical part of the global quality organization, and is both a strategic and tactical, hands-on role. Reporting to the Vice President of Global Quality, this position has overall responsibility for EMEA compliance, Fine Chemical Plant (FCP) Quality performance and EMEA Quality Operations performance.

ESSENTIAL FUNCTIONS:

  • Ensures all functions in EMEA business understand their role in delivering Quality Patient Care.
  • Working with Supply Chain to determine batch disposition priorities to minimize patient impact.
  • Commercial Quality Assurance activities for EMEA region including personnel and budget.
  • Ensures all API Manufacturing activities at the FCP maintain compliance with stated regulatory, environmental, and Indivior internal requirements.
  • Commercial product QP release supporting patients’ markets supplied from EMEA and North America region.
  • Quality Assurance data base and documentation systems supporting EMEA commercial activities.
  • Tech Transfer of products into the commercial Pharmaceutical Quality System, PQS, as applicable.
  • Provides strategic and tactical level oversight for quality operations in EMEA and FCP API Manufacturing and Testing.
  • Ensures all facilities and contract manufacturers operate in a state of quality compliance.
  • Develops and leads the EMEA quality team to ensure proper roles and responsibilities.
  • Integrates quality oversight and operations effectively with NA and AuA Regions.
  • Responsible for effective budget planning and identifying continuous improvement opportunities.
  • Leads diligence and compliance support for new product market entries.
  • Key member of the Quality Leadership Team (QLT).
  • Accountable for ensuring Launch and Annual Product Stability programs.
  • Management review of Quality and Quality objectives established within Indivior and with key contractors.

MINIMUM QUALIFICATIONS:

  • Bachelor of Science degree in a life science or engineering.
  • Proven track record in the pharmaceutical, biopharma or biologics industries.
  • Expertise managing geographically distributed teams.
  • Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.
  • Solid understanding of finished drug product and drug substance regulatory requirements.

COMPETENCIES/CONDUCT:

  • Strong interpersonal and communication skills.
  • Executive presence for giving presentations and updates.
  • Motivated by delivering high quality patient treatments.

BENEFITS:

  • 3 weeks’ vacation plus floating holidays and sick leave.
  • 401(k) and Profit Sharing Plan.
  • Comprehensive Medical, Dental, Vision, Life and Disability coverage.

COMPLIANCE OBLIGATIONS:

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned.

EQUAL EMPLOYMENT OPPORTUNITY

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