Quality Systems & OPEX Manager

The Global Quality Systems and Operational Excellence (OPEX) Manager 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 role’s focus will be to support the review and approval of all INDIVIOR GxP IT system change controls and validation documents, lead the product quality complaints process, and facilitate global Deviation and CAPA management to support the business.

Requirements

• Bachelor of Science degree in a relevant scientific discipline from an accredited university
• 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

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