Product Quality Lead

Role Summary

Product Quality Lead. Location: Richmond, VA. Reports To: Product Quality Manager. This role supports assigned areas to improve operations, manufacture Indivior batches, reduce lead times and increase capacity, ensuring all materials and products are manufactured, packaged, tested and released in full compliance with cGMP and regulatory requirements.

Responsibilities

• 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 related continuous improvement activities.
• 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 internal audit activities for GMP compliance and to identify and raise GMP issues as they arise.
• Assist Quality Validation Manager with change management and validation activities that may impact product and/or process.
• Assist with changes and additions to SOPs, Work Instructions, specifications and related documents.
• Work with CMO to gather and report Quality monthly metrics.
• Assist in training for new and existing employees.
• Ensure Annual Product Reviews are completed and submitted on schedule.
• Author Annual Product Quality Reports.
• Perform Mock Recall Activities.
• Coordinate Stability Activities supporting Sublocade and ensure batches are placed on Stability.
• Ensure Quality Technical Agreement requirements are met.
• Participate in review, investigations and responses for product quality complaints.
• Perform other duties as needed to support North America Quality team.

Qualifications

• Minimum 5 years of quality experience in a regulated industry (FDA/pharmaceutical/medical device).
• Bachelor of Science in a relevant scientific discipline from an accredited university.
• Broad knowledge of sterile manufacturing and current GMPs, regulatory requirements (EU, Health Canada, TGA, ICH, PIC/S).
• Strong analytical and communication skills; ability to work under pressure and manage data trends.
• Proficient in Microsoft Office and Visio; able to develop measurable implementation plans.
• Travel: Minimum 10%.

Skills

• Quality system management, deviation investigation, CAPA, change management.
• Risk assessment, data analysis, and trend interpretation.
• Effective written and oral communication; collaboration with cross-functional teams.

Education

• Bachelor of Science degree in a relevant scientific discipline.

Additional Requirements

• Proficiency in conducting risk assessments to support deviation investigations, change management and CAPA.