Head, Global Quality GxP Audit Programs - Indivior

TITLE:

Title: Head, Global Quality GxP Audit Programs

Reports To: VP, Quality Management

Location: United Kingdom or United States Indivior Based Offices

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. 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 and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. 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. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:

The Head, Global Quality GxP Audit Programs is a critical part of the global quality organization, with a significant support to and partnership with all GxP Functions within Indivior.  As a member of the Global Quality Leadership Team (QLT), this position reports directly to Vice President, Quality Management. 

The position is a strategic and tactical, hands-on leadership role providing for the oversight, planning, execution, and maintenance of the various GxP and REMS (Risk Evaluation and Mitigation Strategies) audit programs, within R&D and Commercial environments.  Provides audit and compliance guidance, with a focus on risk-based management within the cGMP (Good Manufacturing); PV (Pharmacovigilance); and GCLP (Clinical and Laboratory), and REMSs program areas.  Other positional responsibilities include, but are not limited to, the generation and reporting of audit related metrics, trending, review and escalation of quality business risks, and participation in various quality and business operational forums where applicable expertise is required.  Liaisons within the business to also act as consultants when appropriate, to help drive industry best practices as part of our overall culture of quality.

Lastly, the position works with the QLT to help verify, through the administration of the audit programs, that all cGxP activities carried out by the Indivior Businesses and Legal Entities in all territories, where Indivior medicinal products are marketed, are compliant with regulatory requirements in those territories and are in line with Indivior policies.

ESSENTIAL FUNCTIONS:

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

• Assesses the performance of the Pharmaceutical Quality System (PQS), through the identification of nonconformances and areas of positive performance during execution of the audit programs.
• Works across functional boundaries modelling the Indivior Guiding Principles, to ensure operational alignment and driving continuous improvement.
• Liaison to the operations by identifying potential compliance gaps, and then partners with the business as a consultant, to identify and drive best practices for sustainable solutions.
• Serves as a subject matter expert on international product and process quality regulations, standards, guidance documents and identified industry best practices.

General Leadership

• Develops and leads the Global Quality GxP Audit Program Team to ensure roles and responsibilities are clearly aligned; development of personnel; establishment of succession planning; and, to ensure collaboration across all supported functions.
• In collaboration with Quality Operations, ensures that all Indivior facilities and functions operate in a state of quality compliance to ensure all product that is manufactured is safe, efficacious and effective for intended patient in-use studies and trials. 

Global Quality Audit Compliance

• Maintains risk-based audit plans covering the Pharmaceutical Quality System (PQS) for commercial and R&D activities, and for internal and external processes and key service providers. Strategic audit plans covering all GxP activities are reviewed at least annually and have prospective look ahead (as a guide 3-5 years).

NOTE:  REMSs, while included as part of the overall job scope, is separately considered apart from the GxP activities.

• Generates and executes annual internal audit program for Indivior GxP Functions, suppliers, pre-wholesalers, freight forwarders, and 3rd party service providers that fall under GxP Regulations in all territories where Indivior has businesses, business partners and market product.
• Ensures alignment with Heads of Quality for proper planning and coordination of audit program.
• Maintain risk based strategic audit plans covering GxP audit programs for internal and external processes.
• Generate and execute annual internal and external GxP audit plans. Internal audit plan to include at least critical GxP processes and external audit plan to include key GxP supplier partners.

Management Review of Quality

• Generation of Key Quality Compliance indicators to give focus and drive actions at Area and Functional Lead level.
• Assists in participating, gathering information for and presenting information at scheduled management reviews.  Provides clear visibility of risks and risk reduction actions, including independent tracking and escalation of commitments.
• Generation of audit compliance and trending metrics and reporting to respective lead teams.

Issue management

• During audit lifecycle activities, ensure any potential quality incidents are identified and escalated to the appropriate function for action.
• Review the learnings from all critical and major audit observations to assess if systemic gaps within suppliers and internal Indivior entities exists, and any potential changes needed to the QMS.

Regulatory and Competent Authority Inspections

• Assist with inspection readiness efforts, for Indivior and affiliates, for external inspections by Regulatory Authorities, in any Indivior business unit in the Area.
• Co-ordinate follow ups and ensure responses after external inspections.

MINIMUM QUALIFICATIONS:

Education:  Bachelor of Science degree in a life science or engineering discipline. Post graduate degree is preferred.

Field of Study:  Life Sciences, Engineering, Quality

Industry:  Pharmaceutical, Medical Device, Biopharma

Computer Skills: eQMS (Veeva, TrackWise); Proficient in Sharepoint and Microsoft suite of software (Power point, Word, Excel, Outlook)

Experience:  Minimum 15+ years with a proven track record in pharmaceutical, med device or biopharma.

COMPETENCIES/CONDUCT:

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

• Good communication skills and able to debate and negotiate with personnel from all supply functions personnel.
• Well-developed influencing skills. 
• Diplomatic and tactful in difficult situations.
• Highly motivated and confident. Organised and able to deliver concise written or oral summaries to senior management.
• Able to lead on improvement plans within factory, requires a good manufacturing knowledge and an understanding of factory/quality management system.
• Able to train and coach others in risk assessment and auditing techniques.
• Persistent and driven to achieve a final solution. A complete finisher.
• Expert working knowledge of regulations that impact Indivior globally.
• Strong planning and organisation skills.
• Auditing skills, appropriate qualifications in auditing a must.

PREFERRED QUALIFICATIONS:

• Strong interpersonal and communication skills and ability to communicate clearly to all levels of the business, able to deliver concise written or oral summaries to senior management.
• Executive presence for giving presentations and updates is helpful.
• Influencing skills in areas with no direct reporting authority.
• Motivated by delivering high quality patient treatments in the arena of addiction.
• Proficient in English.  However, fluency in other languages is advantageous.

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