Head of QA and QC, FCP

* 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.* 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* 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.* 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.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:Risk IQ: Know what policies apply to your role and function and adhere to them. 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.**Passion. Innovation. Achievement.** All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient.The Indivior leadership team has built a global organization of individuals connected by a thriving culture. Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. It is our set of “Guiding Principles” that we believe have nurtured our culture and successfully guided our decision making.# **Indivior Guiding Principles:*** ## Focus on Patient Needs to Drive Decisions* ## Believe that People’s Actions are Well Intended* ## Seek the Wisdom of the Team* ## Care Enough to Coach* ## See it, Own it, Make it Happen* ## Demonstrate Honesty and Integrity at All TimesFor those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you. #J-18808-Ljbffr