JOB OVERVIEW
We are seeking a highly skilled and experienced Senior Manager or Manager of Good Clinical Practice (GCP) Quality Assurance to join our team. This role is responsible for conducting GCP audits, providing consultations, and supporting clinical trial activities for our Research and Development (R&D) division.
This role will involve strategic planning and implementation of GCP principles, supporting inspection readiness activities, and leading the Quality Management System (QMS) initiatives. The ideal candidate will possess significant decision-making authority on clinical quality matters and ensure the efficient operation of the QA department.
KEY RESPONSIBLIITIES
Conduct GCP Audits and Provide Consultations:
• Perform on-site and virtual audits of clinical investigator sites, processes, documents, and vendors including CROs, central labs, IVRS, and data management.
• Offer expert consultations and clinical trial support to R&D teams. Serve in an Advisory Role for R&D:
• Advise Clinical Operations, Clinical Development, Statistics, Programming, Regulatory Affairs, Pharmacovigilance, and other R&D functions.
• Review and provide feedback on clinical documents including protocols, consent forms monitoring plans, and data management plans.
Quality Assurance Activities:
• Oversee quality assurance activities related to clinical, bioanalytical, diagnostic, safety, an pharmacokinetics analyses of clinical studies.
• Ensure all activities comply with GCP guidelines and regulatory requirements.
Lead GCP Inspection Readiness Activities:
• Prepare for and lead GCP inspection readiness activities, including preparation, hosting, and responding to findings from regulatory inspections.
• Develop and implement strategies to maintain continuous inspection readiness. Decision Making on Clinical
Quality Matters:
• Exercise significant decision-making authority on clinical quality matters, including addressing serious GCP breaches.
• Provide guidance and recommendations for resolving quality issues. Support Quality Management System (QMS):
• Author and review Clinical Quality Assurance (CQA) Standard Operating Procedures (SOPs).
• Review and ensure alignment of functional area SOPs with GCP and regulatory standards. Collaboration and
Communication:
• Work closely with cross-functional teams to ensure alignment and compliance with GCP.
• Provide training and mentorship to team members on GCP and quality assurance practices. Continuous
Improvement:
• Identify areas for improvement in clinical processes and practices.
• Develop and implement corrective and preventive actions (CAPAs) to enhance quality and compliance.
Leverage International Experience:
• Utilize extensive experience working with US and European companies to navigate and comply with varying regulatory requirements.
• Facilitate global clinical trials and ensure adherence to multinational GCP standards.
QUALIFICATIONS
• Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Medicine). Advanced degree preferred.
• Minimum of 15+ years of experience in clinical research quality assurance or a related field.
• Extensive knowledge of GCP guidelines and regulatory requirements.
• Proven experience in conducting GCP audits and inspections.• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a multidisciplinary team.
• Certification in GCP or related areas is a plus.
• Extensive experience working with US and European companies.
USD 4,500/month (CLT) + all major benefits