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Purdue Pharma L.P. · 17 hours ago

Senior Quality Specialist II, GCP/PV/REMS Quality

Stamford, CT

Full-time

Onsite

Senior Level

6+ years exp

Purdue Pharma L.P. develops, manufactures, and markets medications to meet the evolving needs of healthcare professionals, patients, and caregivers. The Senior Quality Specialist II is responsible for executing and supporting quality programs and overseeing daily quality assurance activities related to Clinical Research, Medical Affairs, and Pharmacovigilance activities, ensuring compliance with federal regulations and company standards.

BiotechnologyHealth CarePharmaceutical

No H1B

Responsibilities

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

Qualification

GCP experienceRegulatory compliancePharmacovigilanceMS Office proficiencyData assessmentChange managementInterpersonal skillsProblem-solving

Required

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 understanding regulatory documents and the drug submission process

Proficiency in assessing data to ensure compliance with applicable GxP regulations and internal SOPs

Current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business

Effective interpersonal, verbal, and listening skills

Knowledge of and adherence to appropriate laws and regulations is critical

Proficient in MS Office software and applications

The ability to anticipate challenges and drive full understanding of problems faced within the team

The ability to drive the analysis and change management process for how we solve problems and reach the goal

The ability to think broadly about the causes of problems, their impact, and their solutions

The ability to implement solutions and controls to prevent future problems and uses experience and awareness to identify problems early

Preferred

Graduate degree (MS preferred) with 6-10 plus years' experience or PhD with 3-6 plus years' experience

Company

Purdue Pharma L.P.

Glassdoor3.2

Purdue and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers.

Founded in 1892

Stamford, Connecticut, USA

501-1000 employees