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Sr. Compliance Specialist

Title: Sr. Compliance Specialist

Reports To: Head, Site Quality

Location: Raleigh, NC

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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

POSITION SUMMARY:

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.

ESSENTIAL FUNCTIONS:

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:

License/Certifications: N/A

Travel: Less than 10% travel.

• Bachelor’s Degree from an accredited university required.
• Minimum five (5) years GMP/GXP Pharmaceutical experience required. 
• Must have an in-depth knowledge of current GMP/GXP as well as FDA trends and guidelines.
• Must have experience reviewing and approving validation documents.
• Must have excellent technical writing skills and technical reviewer experience.
• Must be able to communicate effectively both verbally and in writing with all levels of employees on all aspects of compliance.
• In-depth knowledge of quality assurance terminology, methods, and compliance tools. 
• Computer skills required; experience with Veeva preferred.
• Experience reviewing lab data and audit trail data preferred.
• Must be organized, detailed, and have ability to handle multiple tasks at once and redirect focus based on company's needs. Must be adaptable to schedule changes, shifts in priority and cross-functional task alignment. 
• Proficient with problem-solving and risk mitigation. 
• Must be team focused, motivated and foster a positive and accepting environment. 

COMPETENCIES/CONDUCT:

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

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concepts.
• Embrace Indivior core culture principles.
• Embrace the dynamics of team support, team collaboration and team success. 
• Celebrate the core wins of the organization and empower others to sustain a quality mindset. 
• Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives. 
• Celebrate and embrace diversity, equity, and inclusion.