Indivior · 3 months ago
Product Quality Lead
Richmond, VA
Full-time
Onsite
Senior Level
5+ years expIndivior is a global pharmaceutical company focused on developing medicines to treat opioid use disorder. The Product Quality Lead role is responsible for ensuring compliance with quality standards and regulatory requirements, supporting operations, and improving manufacturing processes.
Addiction TreatmentBiotechnologyCommunitiesHealth CareMedicalPharmaceuticalSocial
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 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
Qualification
Required
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
Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA
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
Company
Indivior
Indivior is a specialty pharmaceuticals business.
1001-5000 employees
H1B Sponsorship
Indivior has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (5)
2023 (5)
2022 (6)
2021 (4)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Piper SandlerOaktree Capital Management
2024-11-05Post Ipo Debt· $400M
2024-07-12Post Ipo Equity
2014-12-23IPO
Leadership Team
Mark Crossley
Chief Executive Officer
Recent News
2026-01-13
2026-01-09
Company data provided by crunchbase