Global Quality, QA Clinical Manager

TITLE:

Title: Global Quality, QA Clinical Manager

Location: Remote or On-site

Reports To: Head, Global Quality GxP Audit Programs

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction – a chronic relapsing disease.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.

POSITION SUMMARY:

Delivery of Indivior (INDV) Good Clinical Practices (GCP) Quality Assurance (QA) audit program. This position plays a lead role within Indivior’s GCP QA process, works closely across Indivior Quality, functional Compliance teams and the Research & Development (R&D) matrix to ensure the R&D Quality Management System (QMS) results in clinical trials meet global regulatory and business requirements. This position represents the company both internally and externally. Lastly, the position helps to drive a ‘culture of quality’ at Indivior.

ESSENTIAL FUNCTIONS:

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

Lead, implement and maintain Indivior’s GCP QA audit program to plan to support aspects of Phase I-IV global clinical trials managed by Global Medicines Development (GMD).
Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
Conduct internal audits to assess effectiveness of Indivior’s GCP QMS and process compliance including Clinical Study Report (CSR) and Trial Master File (TMF) audits.
Maintain the approved supplier list (ASL) for Clinical suppliers.
Ensure timely issuance of audit reports, audit observations, oversee audit response process and drive audits to closure.
Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
Evaluate audit observation trends and compliance risks and escalate to QA Management, as required.
Reporting of key metrics (KPIs), quality metrics, periodic quality reports and audits as needed.
Support the cross functional site Quality Management Review (QMR) meetings.
Maintain and enhance existing procedures including electronic system configuration and reports that are utilized to manage the clinical audit program.
Ensure timely collaboration with Global Medicines Development staff (Compliance and Operations) to ensure any non-compliance is elevated appropriately and addressed in a timely manner.
Advise Global Medicines Development team regarding aspects of GCP and compliance to standard operating procedures and regulatory requirements.
Prepare Quality Agreements for review and approval, as applicable.
Lead specific global R&D initiatives aimed to strengthen the Quality Management System, as required.
Maintaining current working knowledge of regulations that impact on role.

MINIMUM QUALIFICATIONS:

Education and Experience:

Bachelor of Science or Bachelor of Arts degree in a life science. Post graduate degree is preferred.
Proven track record of GCP QA auditing experience in a regulated industry such as FDA, pharmaceutical or biotech.
Ability to travel with adequate notification approximately 30% of working hours is required.
Thorough understanding of regulatory requirements for the conduct of clinical trials for drug product, devices or combination products. GCP audit experience in the North America and EU required.

Clear understanding of international guidelines (ICH, cGCP) including study conduct, statistics and data management.

Practical demonstrated application of drug/combination product regulatory requirements (e.g. Clinical Trial Regulations (ICH E6(R2), E2A, E8(R1) and 21 CFR Part 50) and GLP Regulations (Directive 2004/9/EC; 21 CFR 58).
Prior experience working with CROs and/or outsourced organizations is a definite plus.
Experience in Competent Authority inspections.
Demonstrated ability in using continuous improvement techniques to contribute to a pharmaceutical QMS (eg. Root Cause Analysis, etc.)
Experience in auditing REMS programs and/or Pharmacovigilance activities is a plus.

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.

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

Indivior Glassdoor Company Review

3.5

Indivior DE&I Review

No rating

CEO of Indivior

Mark Crossley

Approve of CEO

By Indivior

Since our inception, we have actively partnered with healthcare professionals, the public health community, policy makers, and payers to humanize people suffering from addiction and to treat addiction as a chronic, relapsing medical condition rath...

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FUNDING

Public

INDUSTRY

Biotech & Pharmaceuticals

TEAM SIZE

501-1000

LOCATION

Hybrid, based in Richmond, VA

DATE POSTED