Manager, Compliance Quality Assurance

TITLE:

Title: Manager, Compliance Quality Assurance

Reports To: Head, Site Quality, Raleigh

Location: Raleigh, NC

Indivior 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 the chronic conditions and co-occurring disorders of OUD. Indivior is 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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team.   The scope of responsibilities includes managing site Quality events within the eQuality Systems, ensuring site Compliance, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, site self-inspections, and Bulk Product dispositions.  This role will liaise with the Head of Quality Systems & OPEX to ensure that processes developed at the Raleigh site ensure a state of control and are compliant with regulatory requirements set forth in Indivior’s Quality Management System.  The CQA Manager will support audits directed by the Global audit function and maintains the site in a constant state of inspection readiness. The CQA Manager will be expected to support the Head of Site Quality in regulatory site inspections. The CQA Manager prepares/reviews site Quality Metrics for management review and makes recommendations for continuous improvement.

ESSENTIAL FUNCTIONS:

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

• Supervise, develop, manage, and train direct reports in Quality Systems and Lot Release.  
• Effectively hire, coach, and motivate staff.  
• Write and administer performance appraisals for department personnel.  
• Develop, support, and sustain appropriate metrics including processing and preparing trend data for presentation to management during monthly and quarterly reviews.
• Manage the APQR process and deliver approved reports on time per the approved schedule.
• Manage the Document Management System; create, review, and approve documents including SOPs, WIs and protocols.  Manage periodic document reviews while meeting review dates.
• Collaborate with the Global audit function to develop the annual supplier audit schedule and manage completion of audits against the schedule.  Manage the approved vendor/supplier site list for the site.
• Establish annually the internal audit schedule and manage completion of the internal audits against the schedule.
• Ensure the site maintains a constant state of inspection readiness.  Lead the back room during regulatory inspections and customer audits.  Act as back up to the inspection host.
• Issue batch records to operations in support of the schedule.
• Ensure timely disposition of semi-finished Drug Product.
• Ability to conduct root cause analysis and risk assessments.
• Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility.
• Ensure that the site and quality systems remain in compliance with changes to regulatory requirements.
• Provide regulatory expertise to the technology transfer process, as needed.
• Assure job objectives are met on a timely basis and escalate quality issues to the Site Head of Quality.
• Proactively drive a culture of continuous improvement.
• Communicate effectively/efficiently with others in a professional manner.
• Manage a wide variety of tasks under critical time constraints.
• Other activities as required.

MINIMUM QUALIFICATIONS:

License/Certifications: N/A

Travel: less than 10%

• Bachelor of Science degree in a relevant scientific field required.
• Minimum ten (10) years of experience in pharmaceutical manufacturing required.
• Minimum five (5) years of progressive supervisory experience in pharmaceutical manufacturing required.
• Prior Quality System Management experience.  Experience in VeevaVault preferred.

• In depth knowledge and experience with USP, CFR, ICH, and ISO regulations as well as current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S preferred.

• Experience in a sterile manufacturing environment required.
• Combination Product experience a plus.
• Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, and GDPs preferred.
• Advanced computer skills, knowledgeable of data analysis, and statistical methods.
• Successful implementation of continuous improvement opportunities.
• 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.
• Excellent communication both written and oral and problem-solving skills.
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
• Proven ability to work under pressure without compromising deliverables.
• Ability to collect, understand and interpret data trends on the quality system performance.
• Strong computer skills including Microsoft platform and Visio.

COMPETENCIES/CONDUCT:

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

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma principles.

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 discount 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 and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Leverage Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gym, fitness facility and cell phone discounts
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

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 behavior. As part of your responsibilities, you are expected to:

Employee Obligations:

• 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.

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