Director, FCP Quality, Compliance & Licensing

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Director, FCP Quality, Compliance & Licensing

The responsibilities of this job include, but are not limited to, the following:

• Ensures all functions within the GxP business understand their role in delivering Quality Patient Care.
• Ensures all applicable licensing is current and meets regulatory, state and market requirements.
• Maintenance and development of Area and local Indivior Pharmaceutical Quality System (policies, procedures and working practices) to meet Indivior and Competent authority requirements.
• Integrates quality oversight and operations effectively with global Quality Operation, Site Quality, Global Audits and Quality Systems & OPEX teams to ensure compliant, yet efficient release and disposition of products globally.
• Accountability for key metrics (KPIs) in relation to third party API operations and FDP dispositions, periodic quality reports, and audits as needed.
• Hosting regulatory inspections, supporting internal audits as well as audits of key API/Raw Material suppliers.
• Management of Product Quality Complaints, as requested.
• Escalation of product and process quality issues and identified risks to the QLT and Supply Leadership Team (SLT) and Indivior Quality Council (IQC) as appropriate.
• Ensures all API Manufacturing activities at the FCP and third party, maintain compliance with stated regulatory, environmental, and Indivior requirements.
• Timely disposition of Commercial and R&D API product release supporting patients’ markets.
• Leadership of the QC laboratory activities, ensuring the lab operates to Good Quality Control Laboratory Practice
• Method Transfers of API into the commercial Pharmaceutical Quality System, PQS, as applicable.
• Successful Competent Authority and Client Inspection outcomes through effective planning, preparation and hosting.
• Aligns with team strategy with company objectives and annual priorities, translating them into operational improvements.
• Drives initiatives using team resources, focusing on significant improvements in QA and QC operations.
• Centralize licensing to ensure compliance across all regions and Home Office and GxP regulatory requirements. Ensures global licensing is compliant with all market requirements.
• Ensures compliant drug substance product is dispositioned and available to support the manufacture of DP both internally and externally.
• Ensuring the teams maintain responsibility for the Responsible Person (RP) role which oversees and ensures compliance with GDP guidelines, safeguarding the quality and integrity of medicines during storage and transport and to ensure products are distributed in market.
• Responsible for Quality Technical Agreements and Annual Product Reviews managed out of this team.
• Management and development of the Quality Team members.
• Deliver Quality Management Reviews at a site level for the leadership team and establish effective levels of Operational / Quality meetings as appropriate for the site.
• Deliver Quality Improvement Plan for the FCP site and regularly review and update.
• Deliver timely batch release activities for manufactured and tested API.
• Lead Quality oversite of Tech Transfer, process and methods, of APIs into the FCP.
• Maintenance and continuous improvement of the FCP Quality Management system.
• Generation, review, approval and communication of Product Quality Reviews for API and that ensuring that any recommendations are included in FCP quality improvement plans.
• Coaching and training of cGMP best practice across the FCP site.
• Identification, communication and the ongoing removal quality and compliance risks through the implementation of effective risk management systems.
• Management and delivery of FCP self-inspection program.
• Review and approval of all GMDP related documentation that supports FCP manufacturing, QC laboratory operations and Distribution activities.

Education: Minimum of Bachelor of Science (BSc Hons) degree in a life science or engineering. or equivalent.

Field of Study: Chemistry, pharmacy, engineering or microbiology.

• Proven track record in a direct leadership role within pharmaceutical, biopharma or biologics industries with emphasis on API manufacture and…