Quality Systems & OPEX Manager (Change Management)

Indivior•Richmond, VA

5d•Hybrid

About The Position

The 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.

Requirements

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.
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.

Nice To Haves

Lean Six Sigma Green Belt certification or Project Management certification preferred.

Responsibilities

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.
Ensure Quality SharePoint sites and intranet sites are maintained.
Proficiency in conducting Risk Assessments to support deviations, change management and CAPA.

Benefits

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