Indivior · 4 months ago
Quality Systems & OPEX Manager
Richmond, VA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expIndivior is a global pharmaceutical company dedicated to transforming opioid use disorder into a recognized and treated chronic disease. The Quality Systems & OPEX Manager will play a crucial role in establishing and maintaining Quality Systems while driving a culture of quality across the organization, focusing on compliance, risk reduction, and operational excellence in the Pharmaceutical Quality System.
Addiction TreatmentBiotechnologyCommunitiesHealth CareMedicalPharmaceuticalSocial
Responsibilities
Cross-functional influence to create strategic plans to ensure establishment and lifecycle management of a compliant Pharmaceutical Quality System (PQS) which contains over 100 cross-functional processes
Oversee and action GxP IT systems change controls and validation documents such as quality assurance plans, test scripts and other documents as required; also supports technical transfer, testing, qualification and validation
Write, review and/or approve validation protocols and reports
Provides GxP IT support to INDIVIOR reviewing and approving IT change controls quality assurance plans and other validation records
Participates in 3rd party validation planning meetings and communicates key information to INDIVIOR stakeholders as related to IT systems
Lead the management and triage of product quality complaints
Identify and report appropriate process and IT system metrics and trends to functional heads to drive compliance. Ability to interpret metrics and trends and based on this, identify areas of improvement
Provide direct assistance to the Quality Operations teams for the resolution of quality events
Act as a process owner for Quality Management System processes
Act as IT system Superuser (if the process uses an IT system) and able to support and advise on IT system changes and carry out execution of test scripts when required
Ensures compliance and reduced Regulatory risk in the PQS
Ensures PQS processes are effective, enabling commercial product release supporting patient’s markets supplied globally
Provide direct oversight and influence for the PQS processes (where the Quality Systems team does not have Process Ownership) and work with stakeholders to identify and rectify compliance gaps and improvements
Utilize continuous improvement methodology and deployment across functions to improve processes. This includes Lean Six-Sigma methodologies and project management
Provide direct support for all related continuous improvement activities as applicable
Assist Indivior Head, Quality Validation and Validation Manager in providing support in IT change management and validation activities that may impact product and/or process
Assist in providing support for all GxP changes and additions to SOP, Work Instruction, specifications and like controlled documents
Monitor and improve the health and execution of owned process(es) through metrics (process & IT system metrics) and other appropriate control measures, update the documentation periodically or as the process changes and ensure the relevant people are adequately trained for their role in the process
Assist in providing training support for new and existing employees, as needed
Participate in key regulatory inspections and readiness efforts internally and externally as required
Any other duties as determined by management to support the Quality Systems and OPEX team
Qualification
Required
Bachelor of Science degree in a relevant scientific discipline from an accredited university required
Proven track record, minimum eight (8) years of quality experience, in a regulated industry such as FDA regulated, pharmaceutical or medical device
Broad knowledge of current GMPs, regulatory requirements related to international standards including GAMP5, EU, Health Canada, TGA, ICH, PIC/S
Knowledge of sterile manufacturing
Proficient in validation and qualification, risk assessments for equipment, facility and process
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
Advanced computer skills including Microsoft platform and Visio
Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA
Highly skilled at training and coaching others in problem solving, root cause analysis and execution of improvements
Excellent team player, able to work across boundaries to accomplish goals set
Excellent interpersonal and communication skills and ability to communicate clearly to peers and senior management
Influencing skills in areas with no direct reporting authority including senior management
Logical, process-based thinking necessary to work effectively in role
Able to understand different perspectives and deliver the best outcome for the global business
Global role that works across all functions where there is GxP responsibility. Expected to travel to meet the needs of the role
Preferred
Advanced working knowledge of the electronic Quality systems used at INDIVIOR is an advantage (e.g. Veeva, SAP, Success Factors)
Green Belt certified in Lean Six-Sigma preferred
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