Product Quality Manager (PQM)

TITLE:

Title: Product Quality Manager (PQM)

Reports To: Head, Quality Operations, North America

Location: Richmond, VA (Preferred) or Raleigh, NC

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). 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 SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time.  Our purpose is to bring science-based, life-transforming treatments to patients.  We strive to help eliminate the stigma of addiction.  We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation.  We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

This role is responsible to plan, co-ordinate, lead and manage the activities of the Operational Quality Section within the North American region, to ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested, and dispositioned in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and Most of World.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

• Ensures that release documentation provided by third party suppliers complies with all required Indivior and Regulatory standards.
• Provides final INDV oversite of formulation, manufacturing, packaging, and inspection records to ensure GMP completeness, accuracy, and legibility.
• Provides batch disposition of commercial product(s) manufactured in the US and ready for disposition into all authorized markets.
• Manages the quality elements of the Supply Chain for the commercial products manufactured in the US.  This includes managing the quality relationship with the third-party contactors. 
• Works with Supply personnel to foster dynamic working relationships with pre- wholesalers / wholesalers in North America to ensure continuity of patient supply of Indivior products within label requirements.

• Maintains Inspection Readiness of the Product program and supports management during inspections by competent authorities. Ensures all regulatory audit findings are formally closed out.
• Participates in internal audits and remediates any issues to agreed timelines.
• Executes external audits of North American suppliers per the approved audit schedule, as required.  Follow up and complete and CAPAs required.

• Actively monitors and manages change controls, deviations, customer complaints and has quality oversight/approval to ensure compliance with the current Market Authorisations.
• Critically reviews investigations and responses for product quality complaints.
• Ensures Quality Technical Agreements between Indivior and any third parties are current, approved and are underpinned by regulatory requirements.
• Ensures third party activities in North America under Indivior control (manufacturing, packaging, distribution, co-packing etc) meet all regulatory and Indivior requirements.
• Performs periodic mock recall exercises according to local recall SOP’s.
• Reviews the learnings from all quality issues and failures to decide whether changes are required to the eQMS.
• Raises deviations and leads investigations, root cause analysis and CAPA identification on a case-to-case basis. 
• Must be proficient in root cause analysis and identifying the appropriate solutions/corrective and preventive actions
• Must have strong leadership and communication and able to facilitate investigations across multiple functions and complete within the required timelines
• Drives completion of deviations and ensures CAPA have been implemented and monitored for effectiveness to ensure Indivior has a quality centric continuously improving business.
• Calculates and compiles the results of defect levels from each batch along with other identified Key Performance Indicators (KPIs).  Communicates any trends to Indivior senior management as well as CMO governance team routinely.
• Performs Product Quality Reviews per approved schedule to ensure any quality improvements are identified, logged and tracked to completion.
• Participates in and provide quality input to project teams supporting new product launches.
• Participates in New and Existing Product development through the technical transfer process.
• Participates in Continuous Improvement activities including procedural enhancements to support the commercial activities in North America.
• In conjunction with Global Quality Management and the OPEX team, develops and carrys out training programs to ensure relevant Indivior policies/procedures and local QMS requirements are relayed to appropriate staff.
• Any other duties as determined by management to support North America Quality team.
• Some US and International travel required (approximately 10%) to support vendor relations, audit program and work with the global quality team.

MINIMUM QUALIFICATIONS:

• Bachelor of Science degree, minimum, in a relevant scientific discipline.
• Proven track record, 10+ years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
• Direct experience in finished product dispositioning.
• Direct experience in reviewing manufacturing and packaging batch records as well as analytical testing results.
• Direct experience in Root Cause Analysis and critical thinking.
• Microbiological experience, a plus.
• 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.
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
• Strong Leadership, communication and listening skills.
• Excellent communication skills - presentation, written and oral.
• Proven ability to work under pressure without compromising deliverables.
• Collects, understands, interprets, and trends data on quality system performance.
• Strong computer skills including Microsoft platform and Visio.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

• Proficiency in Risk Assessment skills to support deviation investigations, change management and CAPA.

TRAVEL: Less than 10% travel.

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:

• 3 weeks’ vacation plus floating holidays and sick leave
• 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

GUIDING PRINCIPLES:

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

COMPLIANCE OBLIGATIONS:

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:

Employee Obligations:

• Always act with honesty and integrity.
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Always act with honesty and integrity
• 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.

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.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled