Head of QA and QC, FCP

TITLE:

Title: Head of QA and QC, FCP

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

Location: Hull, UK

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.

Leadership of the FCP Quality Control Laboratory activities to deliver a Culture of Quality and Quality Readiness mindset within the FCP that results in successful Competent Authority and Client Inspection outcomes through effective planning, preparation and hosting.

Leadership of the FCP QA and QC teams to deliver on technology transfer and validation activities associated with API product pipeline.

ESSENTIAL FUNCTIONS:

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

• 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 oversite 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 that 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 the 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:

In addition to the minimum qualifications, the employee will demonstrate:

• 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:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes

• 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
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.