Director, Site Quality - Raleigh

Director, Site Quality
- Raleigh

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 OUD, and we are 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 an exploratory pipeline of products designed to expand its heritage in this category.

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.

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.

• Has site decision authority to independently halt operations, reject product, and escalate compliance risks.
• 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.
• 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.
• Provide quality oversite for QA, QC, microbiology, aseptic processing, validation, contamination control, training and site quality systems.
• Responsible for ensuring site processes are in cGMP compliance and establish systems that identify opportunities for process improvement.
• Develops knowledge of and understands regulatory requirements such as 21
  
  CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies that apply to the quality role.
• Provides input into the Indivior Pharmaceutical Quality System reducing identified risks accordingly.
• Ensures cGxP and process training is conducted to applicable site associates.
• Establishes and measuring/ reporting on the effectiveness of the QMS.
• Independently and objectively reports on product quality and compliance state-of-control of the site.
• Establishes procedures and specifications for adequate manufacturing control.
• Ensures that the site has a Document Management process for maintaining cGMP documents and records in a state of compliance.
• Manages the performance of laboratory tests and examinations to established method and specifications.
• Ensures investigations of non-conformance are conducted appropriately with root cause analysis performed.
• Approves or rejects components, APIs, raw materials or intermediates.
• Dispositions the…