Product Quality Validation Lead - Indivior

TITLE:

Title:  Product Quality Validation Lead

Reports To: Head, Global Quality Validation and R&D

Location: Raleigh, NC

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:

The Product Quality Validation Lead will support tech transfer and validation activities and is a critical part of the global quality organization. This is both a strategic and tactical hands-on role. This position reports to the Head, Global Quality Validation and R&D and is responsible for understanding the technical details of the assigned drug substance and drug product while also managing the Quality aspects.  This is necessary to confirm compliance to Marketing Authorisation expectations, cGxP requirements, and to appropriately protect product quality and patient safety. This individual is the Quality expert on this product and is responsible for ensuring that the product conforms to all Critical Quality Attributes (CQAs) and meets all Critical Process Parameters (CPPs) at all stages of the manufacturing process during tech transfer and validation

ESSENTIAL FUNCTIONS:

• Serves as a subject matter expert (SME) for all Quality related questions, concerns, or issues related to the Product.
• Interact regularly and collaboratively with cross-functional teams to resolve all GxP related issues effectively including discrepancy investigations, CAPAs, change controls, key process development activities, and continuous improvement process reports.
• Ensures the drug substance and drug product can be sustainably manufactured through applying Quality by Design (QbD) principles and techniques.
• Works cross-functionally to ensure that there is an appropriate quality handoff and transition through PQ/PV and the commercial business.
• Oversight of all GMP Compliance and Operational QA (Quality Assurance) aspects of Product
• Manages any third-party activities (including risks)
• Maintains the Quality Assurance Function, to ensure that products are developed in a compliant and safe manner, and by stated timelines through establishing processes that are efficient and standardized.

• Provides insight into the creation, revision, review, and approval of validation protocols impacting the Product.
• Conduct periodic reviews for adequacy of Validation and Tech Transfer policies and procedures to assist the business in the strengthening of the PQS (procedures and working practices) and to meet current INDIVIOR and regulatory requirements.
• Identify and lead specific global initiatives aimed to strengthen the PQS.
• Provide advice on current inspection trends from Competent Authority information sources.
• In collaboration with the Indivior Quality Audit function, ensures approval of INDIVIOR IMP Contractors responsible for raw materials, API, manufacture, packaging, testing, distribution, and cGxP critical Service Providers.
• Management of internal and external documentation flow for QA activities including change management, deviations, and non-conformances.
• Responsible for a standard approach to Risk Management.
• Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
• Ensure Quality Management Reviews are conducted periodically and report on the quality performance using KPI’s that measure QMS and regulatory compliance and drive improvement.
• Ensures review of risks, quality metrics and CAPA learnings and Global Quality Management level to agree on annual quality improvement objectives.

• Reporting of key metrics (KPIs), periodic quality reports, and audits as needed.
• Management of Stability Data and/or Stability Studies that impact Product
• Other responsibilities, as assigned.

MINIMUM QUALIFICATIONS:  

• Bachelor of Science degree in a life science or engineering discipline. Post graduate degree is preferred.
•    Proven record of accomplishment in Pharmaceutical, Biologics or Medical Device industries in a GxP or R&D environment. Thorough understanding of regulatory requirements for the development, testing, and manufacturing of a drug product, devices or combination pro ducts and the validation / qualification of processes and equipment. Experience in the US, EU and/or Asia is required.

•    Direct experience in tech transferring API and drug products from development through PQ/PV and successful hand off to commercial team for launch.
• Direct experience in process and equipment validation.

•  Clear understanding of cGxP requirements and ability to assess and act upon product safety, quality, efficacy, and compliance risks, for both drug and combination products including Quality oversite of clinical trial conduct and management of product complaints.
•   Risk evaluation and mitigation strategy (REMS) program experience a plus.

• Comprehensive understanding of key pharmaceutical and Quality Management processes, test method verifications/validations and manufacturing and packaging facility requirements is required.

• Practical demonstrated application of drug/combination product regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 CFR Part 210/211, 21 CFR Part 4, 21 CFR 820); Clinical Trial Regulations (ICH E6, E2A, E8 and 21 CFR Part 50) and GLP Regulations (Directive 2004/9/EC 21 CFR 58).
• Prior experience managing contract and/or outsourced organizations is a definite plus.
• Experience in hosting or participating in Competent Authority inspections and communicating with Competent Authority Inspectors and officials.

COMPETENCIES/CONDUCT:

• Strong interpersonal skills and ability to communicate clearly to all levels of the business, via concise written or oral summaries to senior management.
• Experience in production operations a plus.
• Influencing skills in areas with no direct reporting authority.
• Strong planning and organisation skills.
• Auditing skills, appropriate qualifications in auditing are an advantage.
• Motivated by delivering high quality patient treatments in the arena of addiction.
• Proficient in English. However, fluency in other languages is advantageous.

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

• 3 weeks’ vacation plus floating holidays and sick leave
• 401(k) and Profit-Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit-sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Leverage Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gym, fitness facility and cell phone discounts
• 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.

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