Product Quality Lead

**Title:** Product Quality Lead**Reports To:** Product Quality Manager* 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.* 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.**BENEFITS:** Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:Health, Dependent Care and Limited Purpose Flex Spending and HSA optionsVoluntary benefits including Legal, Pet Insurance and Critical Illness coverage Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:Risk IQ: Know what policies apply to your role and function and adhere to them. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined.

The employee may perform other functions that may be assigned.

Management retains the discretion to add or change the duties of this position at any time.**Passion. Innovation. Achievement.** All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient.The Indivior leadership team has built a global organization of individuals connected by a thriving culture. Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. It is our set of “Guiding Principles” that we believe have nurtured our culture and successfully guided our decision making.# **Indivior Guiding Principles:*** ## Focus on Patient Needs to Drive Decisions* ## Believe that People’s Actions are Well Intended* ## Seek the Wisdom of the Team* ## Care Enough to Coach* ## See it, Own it, Make it Happen* ## Demonstrate Honesty and Integrity at All TimesFor those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you. #J-18808-Ljbffr