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Associate Director/Lead GCP Clinical Quality Assurance
Location
United States + 1 moreAll locations: United States, Canada
Posted
7 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
This role is responsible for leading the execution and oversight of clinical quality assurance (CQA) programs, ensuring compliance with ICH-GCP, cGLP, and applicable regulatory standards across assigned trials and programs. The position plays a critical role in risk-based audit planning, inspection readiness, and continuous improvement of clinical processes, systems, and vendor oversight. The ideal candidate is a highly experienced QA professional with strong analytical, leadership, and cross-functional collaboration skills, capable of providing guidance, mentoring junior staff, and influencing quality culture. This role operates in a remote environment with up to 20% travel across North America and Canada and requires strategic thinking, attention to detail, and proactive management of audit findings and corrective actions. You will be instrumental in safeguarding scientific integrity, supporting regulatory inspections, and ensuring the delivery of high-quality clinical data.
- Lead CQA activities for assigned trials, ensuring timely communication of quality risks and compliance issues related to GCP/cGLP.
- Develop, execute, and maintain risk-based audit plans covering internal processes, clinical investigator sites, and vendors.
- Conduct audits, analyze observations, identify non-compliance trends, and implement corrective and preventive actions (CAPAs).
- Author, peer-review, and manage audit reports within the Quality Management System (QMS).
- Support regulatory inspection readiness, including mock inspections, training, and documentation preparation.
- Contribute to the development and continuous improvement of quality system processes, SOPs, and tools.
- Provide mentorship and guidance to junior staff, offering GCP counsel on escalated topics.
Qualifications
- Bachelor’s degree in a scientific discipline preferred.
- Minimum of 7 years’ experience in pharmaceutical or biotech industry with at least 5 years in GCP Clinical Quality Assurance.
- Strong knowledge of ICH-GCP, CFR regulations, and cGLP principles.
- Demonstrated experience in risk-based quality management, quality by design, and Phase I–IV clinical trials.
- Proven ability to conduct internal and external audits, author reports, and manage CAPA processes.
- Experience developing SOPs, work instructions, and reviewing internal clinical, regulatory, and biometric processes.
- Strong analytical, critical thinking, planning, and communication skills.
- Experience in oncology or medical imaging clinical development, pharmacovigilance quality (GVP), and regulatory inspection readiness is a plus.
- Ability to collaborate effectively across all organizational levels and manage processes with a continuous improvement mindset.
- Up to 20% travel primarily within North America and Canada.
Benefits
- Competitive annual salary range: $139,000 – $232,000, plus discretionary performance-based cash incentives.
- Comprehensive health benefits including medical, prescription, dental, and vision coverage.
- Life and disability insurance, pre-tax accounts, and 401(k) plan with company contributions.
- Generous paid time off including vacation, holidays, sick days, and paid parental leave.
- Discretionary annual equity awards depending on role level.
- Opportunity to work remotely with flexible arrangements.
- Collaborative, purpose-driven environment with focus on high-quality clinical research and patient outcomes.
Job Requirements
- Bachelor’s degree in a scientific discipline preferred.
- Minimum of 7 years’ experience in pharmaceutical or biotech industry with at least 5 years in GCP Clinical Quality Assurance.
- Strong knowledge of ICH-GCP, CFR regulations, and cGLP principles.
- Demonstrated experience in risk-based quality management, quality by design, and Phase I–IV clinical trials.
- Proven ability to conduct internal and external audits, author reports, and manage CAPA processes.
- Experience developing SOPs, work instructions, and reviewing internal clinical, regulatory, and biometric processes.
- Strong analytical, critical thinking, planning, and communication skills.
- Experience in oncology or medical imaging clinical development, pharmacovigilance quality (GVP), and regulatory inspection readiness is a plus.
- Ability to collaborate effectively across all organizational levels and manage processes with a continuous improvement mindset.
- Up to 20% travel primarily within North America and Canada.
Benefits
- Competitive annual salary range: $139,000 – $232,000, plus discretionary performance-based cash incentives.
- Comprehensive health benefits including medical, prescription, dental, and vision coverage.
- Life and disability insurance, pre-tax accounts, and 401(k) plan with company contributions.
- Generous paid time off including vacation, holidays, sick days, and paid parental leave.
- Discretionary annual equity awards depending on role level.
- Opportunity to work remotely with flexible arrangements.
- Collaborative, purpose-driven environment with focus on high-quality clinical research and patient outcomes.
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