Sr. Compliance Specialist

Sr. Compliance Specialist

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 the chronic conditions and co-occurring disorders of OUD. Indivior is 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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide.

The Sr. Compliance Specialist supports the Quality and Compliance systems at the Raleigh facility. This role is responsible for the management of Change Control and CAPA records, the authoring of Quality Agreements and APQRs and the site self-inspection program. The Sr. Compliance Specialist will have a high level of interaction and influence within the site and is expected to drive improvements to the systems for which the role is responsible.

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

• Develop, implement, and maintain systems and procedures to ensure a high level of inspection readiness and regulatory compliance.
• Participate in multi-functional project teams as a Quality Compliance representative as directed by the CQA Manager or Site Quality Head.
• Develop and participate in compliance initiatives based on new regulations, guidance documents and industry standards.
• Function as a change controller and CAPA manager for site records.
• Facilitate the compilation of data, and author the Annual Product Quality Review reports.
• Author Quality Agreements
• Create the self-inspection schedule, perform self-inspections, write audit reports, and follow up on observations and non-conformances.
• Participate in customer and regulatory audits, as required.
• Participate in the review and approval of GMP documents including, but not limited to procedures, validation protocols, engineering documents and critical work orders.
• Manage vendor-initiated changes and vendor complaints.
• Responsible for compiling and reporting metrics related to site compliance.
• Perform QA review and approval of incoming materials in the ERP System, as required.
• Provide support and guidance to ensure GDocPs are applied throughout the Raleigh Site.
• Track open records in eQMS to include Deviations, Environmental Excursions, OOS investigations, CAPAs, and Change Controls to closure. Design and implement action plans to ensure compliance with procedural requirements.
• Drive compliance initiatives based on new regulations, guidance documents, industry standards and Indivior global procedures as they apply to the site.
• Perform lab data and audit trail review as needed.
• Other duties and responsibilities as assigned

Minimum Qualifications :

Competencies / Conduct :

Benefits :

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.

Compliance Obligations :

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior. As part of your responsibilities, you are expected to :

Manager Obligations :

Equal Employment Opportunity :

EOE / Minorities / Females / Vet / Disabled