Associate Director, Clinical Development and Pharmacovigilance

Job Description: • Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs. • Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements. • Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams. • Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations. • Provide QA support for global PV activities, including adverse event (AE) reporting, signal detection, and safety data exchange agreements. • Monitor compliance with global GVP requirements, including FDA, EMA, MHRA, Health Canada, and other health authorities. • Support audits and inspections of PV systems and processes, including preparation, participation, and follow-up on corrective/preventive actions (CAPAs). • Review and manage deviations, CAPAs, and change controls associated with Clinical and PV activities. • Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations. • Support continuous improvement initiatives across Clinical QA and PV QA functions. • Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates. • Serve as a QA liaison between Clinical Operations, Pharmacovigilance, Regulatory Affairs, and external partners (CROs, Safety Vendors). • Support training and awareness of GCP, GVP, and corporate quality policies across internal teams and contractors. • Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections. Requirements: • Bachelor’s or advanced degree in Life Sciences, Biotechnology, Pharmacy, or related field. • Minimum of 10 years of experience in Quality Assurance within Clinical Operations and/or Pharmacovigilance, preferably in biologics or biotechnology. • Strong knowledge of global regulatory requirements: ICH-GCP, EU GCP Directive/Regulation, FDA GCP regulations, and international GVP standards. • Experience with CRO and PV vendor oversight, including audits and inspections. • Familiarity with electronic systems for clinical and safety data (e.g., EDC, CTMS, Argus, ARISg, Veeva Vault). • Demonstrated success in managing quality issues, audits, and regulatory inspections. • Excellent communication, organizational, and interpersonal skills with the ability to influence and collaborate across functions and geographies. Benefits: