Clark Davis Associates
Overview
The Senior Director GCP Quality Lead will play a key role in developing and executing the global CQA strategy to ensure the highest standards of quality and compliance across clinical programs. This position will oversee audit and inspection activities, manage quality issues, and maintain robust GCP processes. This is a high visibility position with great impact potential. This role is primarily remote but requires on-site presence for
2–4 days monthly
to support audits, inspections, and key business activities. Responsibilities
Lead the design and execution of the global Clinical Quality Assurance (CQA) strategy, ensuring compliance across audits, inspections, and the Quality Management System. Oversee complex site, vendor, and process audits while providing hands-on guidance and mentorship to junior auditors. Drive global quality initiatives that enhance operational excellence, promote continuous improvement, and align with business objectives. Anticipate and mitigate emerging quality risks through proactive collaboration with cross-functional and regional teams. Champion the integration of digital tools and data analytics to strengthen inspection readiness and quality oversight. Manage and develop a high-performing CQA team, fostering accountability, engagement, and professional growth. Requirements
Bachelor’s or Master’s degree in a scientific or related field with
15+ years of experience
in clinical development, operations, or regulatory compliance within pharma/biotech. Extensive
Clinical Quality Assurance (CQA)
background with hands-on experience conducting and leading a wide range of
GCP audits . Proven record in
developing quality strategies , managing complex cross-functional initiatives, and leading teams to deliver operational excellence. Travel : Up to
20%
for audits, inspections, and key business activities. Seniority level
Director Employment type
Full-time Job function
Quality Assurance Industries: Pharmaceutical Manufacturing and Biotechnology Research
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The Senior Director GCP Quality Lead will play a key role in developing and executing the global CQA strategy to ensure the highest standards of quality and compliance across clinical programs. This position will oversee audit and inspection activities, manage quality issues, and maintain robust GCP processes. This is a high visibility position with great impact potential. This role is primarily remote but requires on-site presence for
2–4 days monthly
to support audits, inspections, and key business activities. Responsibilities
Lead the design and execution of the global Clinical Quality Assurance (CQA) strategy, ensuring compliance across audits, inspections, and the Quality Management System. Oversee complex site, vendor, and process audits while providing hands-on guidance and mentorship to junior auditors. Drive global quality initiatives that enhance operational excellence, promote continuous improvement, and align with business objectives. Anticipate and mitigate emerging quality risks through proactive collaboration with cross-functional and regional teams. Champion the integration of digital tools and data analytics to strengthen inspection readiness and quality oversight. Manage and develop a high-performing CQA team, fostering accountability, engagement, and professional growth. Requirements
Bachelor’s or Master’s degree in a scientific or related field with
15+ years of experience
in clinical development, operations, or regulatory compliance within pharma/biotech. Extensive
Clinical Quality Assurance (CQA)
background with hands-on experience conducting and leading a wide range of
GCP audits . Proven record in
developing quality strategies , managing complex cross-functional initiatives, and leading teams to deliver operational excellence. Travel : Up to
20%
for audits, inspections, and key business activities. Seniority level
Director Employment type
Full-time Job function
Quality Assurance Industries: Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr