Supplier and Customer Management (Audits and Technical Agreements)

• Onboard FCP suppliers and service providers in accordance with Indivior policies and procedures.
• Maintain the FCP Approved Suppliers lists.
• Implement and maintain Technical Agreements with suppliers and service providers, where required.
• Manage the FCP supplier audit schedule.
• Work with FCP suppliers and Procurement to schedule audits in compliance with the approved audit schedule.
• Perform supplier audits, support Global Audit team as an API manufacture SME.
• Manage and support close out of CAPA plans where required following audits.
• Manage the system for the continued review / reporting for supplier status and alert reporting through direct communication with the service providers and resolve issues before escalation.

Good Distribution Practice

• Ensure that all GDP requirements are met according to Indivior policies and procedures and applicable GxP requirements.
• Perform Bona Fide checks on suppliers and customers in accordance with Indivior policies and procedures.

Batch Record Review and Release

• Review and approve production batch records for intermediates and finished product to assure manufacturing schedules are maintained and supported.
• Support internal partners with training on correct completion of batch records and associated quality records to continuously improve quality standards and compliance.
• Generation and approval of CoAs.
• Implementation and ongoing management of contracted microbiological testing.

Training

• Generate and maintain training matrix for GMP impacting processes and procedures, support creation and maintenance of role specific curricula in the LMS.
• Act as LMS superuser for the FCP support administration and use of the system through technical support and training.
• Assess Indivior global SOPs to assure FCP policies and procedures are aligned.
• Monitor completion of training items escalating any overdue items to the FCPLT.

Management of On-going Stability of API’s manufactured at the FCP

• Including generation and approval of protocols and data tables, co-ordination of timepoint sample analyses, review and approval of report both internally and at third parties.

Validation and Qualification

• Manage the validation and qualification process (including cleaning) at FCP, ensuring producers and templates are maintained in the eDMS.
• Act as quality approver for validation documents.
• Ensure completed validation documents are stored in the eDMS.
• Implement and manage a continuous verification process for the manufacture of APIs.

MINIMUM QUALIFICATIONS

• Education: Batchelor of Science degree is preferred but not essential.
• Field of Study: Chemistry, Biology, Pharmacy or similar.
• Experience: Minimum of 5 years in a GxP environment, ideally but not necessarily in the API manufacturing area.
• Travel: International and domestic travel will be required for audit, meetings, conferences etc.

COMPETENCIES/CONDUCT

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

• Highly motivated and flexible approach to results delivery.
• Solid competencies to manage multiple tasks and priorities within a fast-paced, entrepreneurial environment.
• Excellent communication skills - presentation, written and oral.
• Proven ability to work under pressure without compromising deliverables.
• Strong GxP knowledge predominantly in GMP environments.
• Strong computer skills including Microsoft platform.
• Knowledge of Veeva eQMS an advantage.
• Knowledge and experience of working with controlled drugs.

PREFERRED QUALIFICATIONS

• Pharmaceutical/ISO Auditing Course.

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. 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

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 Times

For 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