Product Quality Lead

Title:

Product Quality Lead

• Title: Product Quality Lead
• Reports To: Product Quality Manager
• Location: Richmond, VA

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 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

Position Summary:

This role is responsible to support the assigned areas in their ability to successfully improve operations, manufacture Indivior batches, reduce lead times and increase capacity. To ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested and released in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and Most of World.

Essential Functions:

The responsibilities of this job include, but are not limited to, the following:

• Provide direct INDV QA assistance for the resolution of deviations, escalations, and material disposition.
• Provide final INDV QA review of formulation, manufacturing, bulk packaging, and inspection records to ensure GMP completeness, accuracy and legibility.
• Provide final INDV QA review of secondary packaging records and activities
• Provide surge support for INDV QA Release for Supply Activities for final commercial batch disposition, as required
• Provide INDV QA review of artwork and component changes
• Provide INDV QA oversight of supplier, component and material changes impacting bulk manufacturing and secondary packaging.
• Provide direct support for all related continuous improvement activities as applicable.
• Assist in providing direction in batch disposition, along with major deviations.
• QA lead or support on writing and investigating minor and major deviations as required
• QA lead or support all on Sublocade Launches
• Assist in providing support in internal audit activities for GMP compliance and to identify and raise GMP issues as or if they arise.
• Assist Indivior Quality Validation Manager in providing support in change management and validation activities that may impact product and/or process.
• Assist in providing support for all changes and additions to SOP, Work Instruction, specifications and like documents.
• Work directly with CMO to gather and report Quality monthly metrics.
• Assist in providing training support for new and existing employees. 
• Ensure that Annual Product Reviews have been completed by responsible parties and have been assessed internally against requirements and are delivered according to schedule.
• Author Annual Product Quality Reports
• Perform Mock Recall Activities
• Coordinate Stability Activities supporting Sublocade and ensure batches are placed on Stability
• Ensure that the applicable Quality Technical Agreement requirements are being met.
• Participate in the review, investigations and responses for product quality complaints.
• Any other duties as determined by management to support North America Quality team.

Minimum Qualifications:

License/Certifications: N/A

Travel: Minimum 10%

• Bachelor of Science degree in a relevant scientific discipline from an accredited university required.
• Broad Knowledge of sterile manufacturing.
• Proven track record, minimum five (5) years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
• Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.
• Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks. Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated.
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
• Excellent communication skills - presentation, written and oral.
• Proven ability to work under pressure without compromising deliverables.
• Collects, understands, interprets and trends data on the quality system performance.
• Strong computer skills including Microsoft platform and Visio.

Competencies/Conduct:

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

• Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA.

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, plus company closure from December 24th- January 1st 
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions 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, Dependent Care and Limited Purpose Flex Spending and HSA options 

• Adoption Assistance

• Tuition Reimbursement

• Concierge/Personal Assistance Services

• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage 
• Gym, fitness facility and cell phone discounts 

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