The Role
Manage Quality Management System processes and change controls, support compliance in pharmaceutical quality, and lead continuous improvement projects.
Summary Generated by Built In
TITLE:
Quality Systems & OPEX Manager (Change Management)WHO WE AREIndivior 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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.This role is hybrid and located in our Richmond, VA HQ.POSITION OVERVIEWThe Quality Systems and Operational Excellence (OPEX), Change Management role is a key part of the global quality organization in establishing and maintaining Quality Systems and driving a “culture of quality” at Indivior. This is not a people manager role, but it is a role with meaningful influence. You’ll work closely with colleagues across Quality, IT, Operations, and other GxP-impacting functions to reduce risk, strengthen compliance, and support the reliable supply of medicines to patients worldwide.HOW YOU’LL MAKE AN IMPACTYour focus will be to own and manage the QMS Change Control and CCRB processes, support review and approval of Indivior GxP IT system change controls and lead continuous improvement projects as related to the QMS.The responsibilities of this job include, but are not limited to, the following:- Partner cross-functionally to support the execution and lifecycle management of a compliant and effective Pharmaceutical Quality System (PQS).
- Own and lead the management and lifecycle of QMS Change Control, including oversight of global and local Change Control Review Boards (CCRB).
- Support review and approval of GxP IT system change controls and validation documentation.
- Identify, trend, and communicate quality process and IT system metrics.
- Act as a process owner for Quality Management System processes.
- Act as an IT system superuser where applicable.
- Apply continuous improvement principles to strengthen processes and reduce regulatory risk.
- Provide direct oversight and influence for owned PQS processes.
- Support changes and additions to SOP, Work Instruction, and like controlled documents.
- Assist in providing training support for new and existing employees for owned processes.
- Support regulatory inspection readiness and participate in inspections as required.
- Minimum 10% travel.
- Bachelor of Science degree in a relevant scientific discipline from an accredited university required.
- Minimum eight (8) years of quality experience in a regulated industry.
- Broad knowledge of current GMPs, regulatory requirements related to international standards including GAMP5, EU, Health Canada, TGA, ICH, PIC/S.
- Proven ability to work under pressure without compromising deliverables.
- Excellent written and verbal communication skills.
- Proactive, organized, and dependable working style.
- Confidence influencing outcomes without direct authority.
- Proficiency with Microsoft tools; Visio and eQMS experience a plus.
- Lean Six Sigma Green Belt certification or Project Management certification preferred.
- Ensure Quality SharePoint sites and intranet sites are maintained.
- Proficiency in conducting Risk Assessments to support deviations, change management and CAPA.
- Strong and confident negotiator understanding optics and soft skills within a corporate environment.
- Excellent team player, able to work across boundaries to accomplish goals set.
- Excellent interpersonal and communication skills with peers and senior management.
- Logical, process-based thinking necessary to work effectively in role.
- Able to understand different perspectives and deliver the best outcome for the business.
- Role that works across all functions where there is GxP responsibility.
- Competitive PTO 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
- Wellness programs as well as other discounts and perks
- 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.
- 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.
Top Skills
Eqms
Gamp5
Lean Six Sigma
Microsoft Tools
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The Company
What We Do
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorder and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in over 40 countries worldwide. Our guiding principles foster a corporate culture of trust, innovation, and a pioneering spirit: • Focus on patient needs to drive decisions • Seek the wisdom of the team • Believe that people’s actions are well intended • Care enough to coach • See it, own it, make it happen • Demonstrate honesty and integrity at all times
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