Head of QA and QC, FCP

TITLE:Head of QA and QC, FCP

Title: Head of QA and QC, FCP

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

Location: Hull, UK

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 to learn more. Connect with Indivior on LinkedIn by visiting

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.

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

R2813