Indivior

Indivior

Director, Site Quality - Raleigh

Raleigh, NC · Director

Sponsorship not specified$200k-$230kDetected 13 days ago
ComplianceAuditingGMPFDA RegulatoryLeadershipCollaborationProblem SolvingOSHA

About the role

  • Has site decision authority to independently halt operations, reject product, and escalate compliance risks.
  • Provides strategic and tactical site level oversight for quality operations.
  • Assigns clear roles and responsibilities in the quality department to assure coverage of all fields of responsibility.

Responsibilities

  • As a Member of the Quality Leadership Team (QLT), the Raleigh Leadership Team, (RLT) and the Site Quality Management Representative, manages and escalates quality and compliance issues to the VP, Quality Management; Director, Quality Ops and Raleigh Site Director, as applicable.
  • Develops site quality strategy to ensure continued release of complaint product in a streamlined manner ensuring product is available to patients without disruption.
  • Attracts, develops and leads the Quality functions at the site including Quality Assurance and Quality Control.
  • Develops knowledge of and understands regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies that apply to the quality role.
  • Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD).
  • Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category.

Requirements

  • In collaboration with Quality Validation and Quality Operations, participates in Technology Transfer activities into commercial supply as required.

Compensation

  • Eligible to receive a yearly grant as part of Indivior's Long-Term Incentive Plan

Benefits

  • Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease.
  • Eligible to participate in Indivior's bonus program, based on company and individual performance
  • Competitive PTO plus company closure from December 24th- January 1st
  • 401(k) and Profit-Sharing Plan- Company match
  • 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

Company info

  • Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.
  • The Director of Quality - Raleigh is a critical part of the global quality organization, and is both a strategic and tactical, hands-on role.
  • This position reports into the VP, Quality Management and is accountable for the quality site organization and the staff that fulfils its regulatory responsibilities by ensuring that all Indivior activities and commercial products, are compliant to Marketing Authorizations and cGxP requirements.
  • The role holds site‑level accountability for sterility assurance, batch disposition, and patient safety in the highest‑risk manufacturing environment, consistent with Director‑level enterprise risk ownership.
  • The role also acts as the primary site representative for FDA and global Health Authority inspections, commits the organization to remediation strategies, and owns critical compliance outcomes.
  • The position scope includes QA, QC, microbiology, aseptic processing, validation, contamination control, training and site quality systems, with membership on the Site Leadership Team.
  • This position will identify and resolve compliance issues in alignment with the global Quality function, implement continuous improvements, and drive a 'culture of quality' at the site.
  • This position must also be able to secure and work cross functionally to support routine commercial manufacturing and compliant and safe drug products.
  • Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
  • 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.

Equal opportunity

  • EOE/Minorities/Females/Vet/Disabled are encouraged to apply!
  • 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.
Apply directly at Indivior →Create a free account for alerts like thisView Indivior immigration profile

This listing is sourced directly from Indivior's careers page and normalized into a canonical job model.