Head of QA and QC, FCP

Indivior PLC; West Carr; On-site; GBP 60,000 - 75,000; Full time

Job summary

A global pharmaceutical company is seeking a Quality Manager at their United Kingdom site. The role involves managing the Quality Assurance and Control teams, ensuring compliance with GMP and regulatory standards, and leading continuous improvement initiatives within the Quality Management System. The ideal candidate will have a degree in Chemistry, Pharmacy, or Microbiology, along with extensive experience in Quality Management and a strong understanding of regulatory requirements. Benefits include flexible working, 25 days holiday, and a company pension plan.

Benefits

25 days holiday plus public holidays

Flexible working; FCP collaboration model

Paid Volunteer Time Off

10% company pension

Optional Health Insurance with BUPA

EAP services including Legal, Health and Wellbeing support

Qualifications

• Proven track record in Quality Management.
• Thorough understanding of regulatory and GMP requirements.
• Laboratory experience within a QC laboratory is desirable.
• Experience in pharmaceutical or API background.
• Experience in dealing with Narcotics is desirable.

Responsibilities

• Manage and develop the Quality Team (QA and QC).
• Deliver Quality Management Review at site level.
• Oversee external regulatory and third-party audits.
• Ensure compliance with GMP and regulatory requirements.
• Coach and train cGMP best practices across the FCP.

Skills

Strong interpersonal and communication skills

Problem-solving abilities

Organizational skills

Ability to influence others

Team training and coaching

Education

Degree or equivalent in Chemistry, Pharmacy or Microbiology

Job description

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.

Key Responsibilities

• 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 oversee 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

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.

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.

Personal Attributes

• 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.
• Fluency in English is essential.
• 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.

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. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

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