The Product Quality Lead will support the assigned areas in improving operations, manufacturing Indivior batches, reducing lead times, and increasing capacity. They will ensure compliance with cGMP and regulatory requirements, and work to improve quality standards for the US and Most of World.
Requirements
- 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.
- 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.
- 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.
Benefits
- 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
