Head of QA and QC, FCP

Reports To: Senior Director, Quality Operations, EMEA & API Manufacturing

Location: Hull, UK

About Indivior: Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease.

Position Summary: An active member of the Fine Chemical Plant (FCP) Site Leadership team and Quality Leadership Team (QLT) contributes to strategic business direction and decisions. Representing Quality at the site leadership team, ensures effective and timely communication of Quality issues and successes, acting as Subject Matter Expert on all API GMP and wider Quality related matters. Leading and managing the QA and QC team in their support of the FCP manufacturing and testing operations, while maintaining continuous improvement of the FCP Quality Management System, ensuring compliance with cGMP, regulatory requirements, Home Office requirements and the Indivior Quality Management System.

Essential Functions:

• Management and development of the Quality Team (QA and QC) based at the FCP.
• Deliver Quality Management Review at a site level for the leadership team and establish effective levels of Operational / Quality meetings as appropriate for the site.
• Deliver Continuous Improvement of the Quality Management System at the FCP site in response to changes in regulations and advances in technology and site operations.
• Management of external regulatory and third-party customer audits received by the FCP.
• Ensure that GMP certification (MHRA and FDA) and Home Office Controlled Drugs Licence is maintained.
• Deliver batch release activities for manufactured API.
• Lead Quality oversight of Tech Transfer of manufacturing process and analytical methods, into the FCP.
• Maintenance and continuous improvement of the FCP Quality Management system.
• Maintenance and routine update of the Site Master File FCP are fully compliant with regulatory requirements (MHRA & FDA as a minimum) and INDV policies and procedures.
• Vendor assurance activities for FCP material and service suppliers.
• QA input to and approval of deviations and change controls.
• Oversight and approval of manufacturing validation / qualification activities.
• Oversight and approval of QC validation / qualification activities.
• Generation of metrics to reflect the health of the QMS.
• Generation, review, approval and communication of Product Quality Reviews for API and ensuring that any recommendations are included in FCP quality improvement actions.
• Coaching and training of cGMP best practice across the FCP site.
• Identification, communication and ongoing management of 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.

Leadership of the QC laboratory activities, to deliver timely and effective:

• Analysis and release of raw materials and intermediates.
• Release of API to agreed schedules.
• Ensuring the Laboratory operates to Good Quality Control Laboratory Practice and appropriate Health and Safety standards.

Minimum Qualifications:

• Education: Degree or equivalent.
• Field of Study: Chemistry, pharmacy or microbiology.
• Experience: Proven track record in Quality Management. Thorough understanding of regulatory and GMP requirements relevant to a regulated product e.g. EU GMP, ICH Q7, WHO, PIC/S, CFR 21 Part 210/211. Laboratory experience within a QC laboratory or an Analytical Laboratory within a GMP manufacturing facility is desirable. Experience in pharmaceutical or API background and/or working to FDA, MHRA, BSI or ISO standards. Experience in dealing with Narcotics is desirable. Experience in technology transfer and qualification an advantage. Auditing skills, appropriate qualifications in auditing an advantage.

Travel: Some domestic Travel is required.

Competencies/Conduct:

• Strong interpersonal and communication skills.
• A high level of ownership is required to ensure that any problems or delays to release are managed to have minimum impact and communicated to those affected.
• A proactive approach and ability to problem solve.
• 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 FCP and operational site, requires a good manufacturing knowledge and an understanding of manufacturing quality management systems.
• Able to train and coach others.
• Persistent and driven to achieve a final solution.
• A completer finisher.
• Flexible to travel, if required.
• The business language is English, therefore fluency in English is essential.

Benefits:

• 25 days holiday plus public holidays.
• Flexible working; FCP collaboration model.
• Paid Volunteer Time Off.
• 10% company pension.
• EAP service including Legal, Health and Wellbeing support.
• Optional Health Insurance with BUPA.
• Company Death in Service and Payment Protection Insurance.
• 3 Celebratory days.
• Access to platform for discounts on such as gym membership, shopping, holidays.

Guiding Principles: Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

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. As part of your responsibilities, you are expected to:

• Employee Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure.
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations: Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure. Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. Model and reinforce a Speak Up culture on your team.

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. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled