Senior Quality Specialist II, GCP​/PV​/REMS Quality

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life‑saving opioid overdose reversal medications and have the capability to manufacture others for medication‑assisted treatment. Providing these medicines has the potential to improve and save countless lives.

Responsible for the execution and support of quality programs and oversight of daily quality assurance activities supporting Clinical Research, Medical Affairs, and Pharmacovigilance activities, Regulatory submissions, and other regulated activities related to compliance with federal regulations and company standards for Stamford operations in Purdue Pharma L.P.

• Participate in the development and execution of a comprehensive annual Good Clinical Practices, Good Laboratory Practices, Pharmacovigilance, and Risk Evaluation and Mitigation Strategy ("GCP/GLP/PV/REMS") audit plan covering internal processes, vendor services and clinical site activities.
• Lead/manage the execution of defined audits utilizing internal/external resources in a cost efficient and effective manner. Ensure post‑audit activities entail timely follow‑up and resolutions.
• Serve as GCP/GLP/PV/REMS subject matter expert on teams. Assure that studies/programs are complete and meet internal standards and regulatory requirements.
• Ensure overall compliance, identify compliance gaps and ensure they are mitigated in a timely manner.
• Ensure project timeline accurately captures all quality activities.
• Review plans and materials for compliance, and contracts/proposals to ensure they adequately capture outsourced QA requirements.
• Lead continuous improvement and remediation for areas identified by audit/inspection and CI team initiatives.
• Collaborate with senior management and relevant stakeholders on corrective actions resulting from audits and regulatory inspections. Lead/manage efforts for verification of necessary completed corrective and preventative actions ensuring that compliance risks are satisfied.
• Internal Customers primarily include Drug Safety and Pharmacovigilance, Clinical Research and Development, Toxicology, Regulatory Affairs, Medical Affairs departments. Collaborate and support ad‑hoc projects that enhance the overall compliance of the Company.
• Ensure pharmacovigilance activities including safety information processing and reporting follow regulations.
• Lead multiple key host roles for regulatory inspections and post inspection follow up and corrective action implementation.
• Lead / manage the quality support role for all post marketing studies, (including epidemiology, non‑interventional studies, abuse deterrent studies) to ensure they are conducted in accordance with regulatory and company standards.
• Remain current on regulatory expectations and best practices through constant monitoring of changes to regulations, guidance documents, and industry trends related to clinical; safety and regulatory reporting.
• Perform other assigned responsibilities as required.

Sr Quality Specialist II must have: BS required and 8 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 6‑10 plus years' experience or PhD with 3‑6 plus years' experience.

• Five years of Safety/GCP experience.
• Proficiency in…