Manager of Clinical Quality Assurance

About the role

The Manager of Clinical Quality Assurance (CQA) is responsible for managing CQA activities, supporting the Head of Clinical Quality Assurance, leading quality oversight of clinical and pharmacovigilance activities, and providing regulatory advice.

Responsibilities

• Evaluate compliance with government regulations, guidelines, and company SOPs.
• Support implementation and continuous improvement of CQA processes.
• Lead audits of clinical investigator sites, trial master files, and vendors.
• Create and execute audit plans to ensure adherence to company SOPs and regulatory requirements.
• Generate and issue audit reports summarizing findings.
• Provide feedback and review audit responses and CAPAs.
• Track and approve CAPA completion.
• Review and approve deviations to internal processes.
• Lead process improvement activities during inspections and audits.
• Develop and maintain departmental SOPs.
• Onboard and mentor new team members.
• Train staff on applicable regulations and guidelines.
• Provide independent regulatory advice to various functions.

Requirements

• Bachelor’s degree in Regulatory Affairs, Health Administration, Pharmaceutical Science, or a related field, plus 5 years of relevant experience.
• Experience in CQA management, auditing, and regulatory environments.
• Knowledge of 21 CFR Part 11, 21 CFR 312, 314, EU Directives, Health Canada Regulations, and ICH E6 (R2).
• Experience with Quality Management Systems.

Qualifications

• Experience in the pharmaceutical, biotechnology, or healthcare industries.
• Strong leadership and interpersonal skills.
• Excellent communication and problem-solving abilities.
• Ability to work independently and manage multiple projects simultaneously.

Skills

• Strong knowledge of GCP, GLP, and GVP.
• Effective communication and collaboration skills.
• Proficiency in regulatory compliance and auditing.
• Ability to lead and mentor a team.

Benefits

Not specified.

Pay

$217,422.00 per year

Schedule

100% remote