Associate Director, Quality Assurance GCP

• Provide strategic leadership and oversight for GCP quality assurance activities supporting clinical development programs.
• Lead the development, planning, and execution of GCP audits, including audits of clinical sites, CROs, vendors, and internal processes.
• Own and drive regulatory inspection readiness, including preparation for FDA and other health authority inspections, inspection conduct, and response to findings.
• Collaborate with Clinical Development and Clinical Operations teams to ensure studies are conducted in compliance with applicable GCP, regulatory requirements, and company SOPs.
• Provide expert guidance in the identification, investigation, and resolution of quality events, including deviations, CAPAs, and audit findings.
• Oversee and maintain the GCP quality systems, including processes for audit tracking, issue management, and quality metrics.
• Contribute to the development, implementation, and continuous improvement of quality systems, SOPs, and policies to support GCP compliance.
• Support cross-functional teams in the preparation and review of clinical documents and regulatory submissions from a quality perspective.
• Manage relationships with external vendors and partners to ensure quality expectations are clearly defined and met.
• Provide mentorship and guidance to junior QA staff and serve as a key quality resource across the organization.

Qualifications:

• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred.
• 8-10 years of experience in GCP Quality Assurance within the pharmaceutical or biotechnology industry.
• Demonstrated experience leading or supporting regulatory inspections (e.g., FDA, EMA) and audit programs.
• Strong understanding of GCP regulations and guidelines, including FDA, EMA, ICH-GCP, and other global regulatory requirements.
• Experience working with and overseeing CROs and external vendors supporting clinical programs.
• Proven ability to manage quality investigations, CAPAs, and inspection readiness activities.
• Strong problem-solving skills and ability to operate effectively in a fast-paced, evolving environment.
• Excellent written and verbal communication skills, with the ability to clearly communicate risks, findings, and recommendations to cross-functional stakeholders.
• Ability to work independently while collaborating effectively across teams and influencing without direct authority.

Salary Range:

$180,000 - 205,000 USD