Manager of Clinical Quality Assurance

American Regent, Inc.

4d•Remote

About The Position

American Regent, Inc. seeks a Manager of Clinical Quality Assurance (CQA) responsible for managing CQA activities related to the development of study-specific audit plans and overseeing clinical quality assurance processes. This role contributes to the quality oversight of functions including Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs. The Manager will evaluate compliance with regulations, guidelines, SOPs, and industry standards, and support the Head of Clinical Quality Assurance in implementing and improving CQA processes. The position is 100% remote.

Requirements

Bachelor’s degree in Regulatory Affairs, Health Administration, Pharmaceutical Science or a related field or foreign equivalent
Five (5) years of experience working in a pharmaceutical, biotechnology, or healthcare environment.
Five (5) years of experience in the management of CQA activities including system/process-related auditing
Five (5) years of experience with Investigator site, CRO, IRB, and Pharmacovigilance auditing experience
Five (5) years of experience with Medicinal product development and global clinical regulatory environment in pharmaceuticals or biotechnology environment including 21 CFR Part 11, 21 CFR 312, 21 CFR 314, EU Directives, Health Canada Regulations, and ICH E6 (R2)
Five (5) years of experience utilizing Quality Management Systems.

Responsibilities

Manage the CQA activities associated with the development of study-specific audit plans and oversight of clinical quality assurance processes that contribute to the quality oversight of functions including Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
Evaluate compliance with all applicable government regulations, federal guidelines, company Standard Operating Procedures, and industry standards.
Support the Head of Clinical Quality Assurance to ensure implementation and continuous improvement of all CQA processes.
Lead quality oversight of assigned animal and/or human clinical study programs including independent planning and execution of audits according to developed study-specific audit plans to assure adherence to company Standard Operating Procedures and other specified standards, and any applicable regulatory requirements.
Lead quality oversight of post-marketing Pharmacovigilance activities for human and animal products.
Develop, plan, schedule, and conduct audits of clinical investigator sites, trial master files, systems/process, clinical study documents, clinical research and Pharmacovigilance vendors.
Generate and issue audit reports to summarize results of conducted audits in accordance with company Standard Operating Procedures.
Provide audit-related feedback to stakeholders.
Review audit responses/CAPA(s) for acceptability and escalate issues in accordance with applicable company Standard Operating Procedures.
Review, approve, and track CAPA completion in accordance with company Standard Operating Procedures.
Close audit reports and file reports and associated documentation in accordance with company Standard Operating Procedures.
Review and approve deviations to internal processes reported by Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
Lead process improvement activities to support inspection preparation/readiness activities.
Lead key activities during regulatory inspections and/or external audits as directed.
Provide management with support for continuous improvement activities.
Lead the development and maintenance departmental Standard Operating Procedures and other Standards.
Provide onboarding support to new CQA team members and mentoring as needed.
Provide training to staff and on applicable regulations and guidelines including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GVP).
Provide independent regulatory requirement/compliance advice to Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs functions.