Head, Global Quality Gxp Audit Programs

2 weeks ago

Richmond, United States Indivior Full time

TITLE:
Head, Global Quality GxP Audit Programs

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.

:
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.

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 trendi

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