GCP Manager; Quality & Compliance

Zydus Therapeutics is a clinical stage, specialty-focused bio‑pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias.

Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions.

Our lead drug candidate, Saroglitazar, is a liver‑selective, dual peroxisome proliferator‑activated receptor (PPAR) alpha/gamma agonist. Saroglitazar has received Fast Track designation and orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of primary biliary cholangitis (PBC). It is also being developed for non‑alcoholic steatohepatitis (NASH). Our second drug candidate, Desidustat, is an oral hypoxia‑inducible factor prolyl hydroxylase (HIF‑PH) inhibitor being developed for chemotherapy‑induced anemia (CIA).

As a wholly‑owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers working with cutting‑edge technologies.

• Ensure all clinical trials are conducted in compliance with ICH‑GCP, regulatory requirements, and sponsor SOPs.
• Provide GCP oversight across Phase I–IV clinical trials conducted globally.
• Interpret and implement GCP regulations, guidance documents, and industry best practices.
• Monitor adherence to protocol, regulatory commitments, and ethical standards.

• Develop and implement Quality Management Systems (QMS) related to clinical research.
• Support implementation of Risk‑Based Quality Management (RBQM) and Risk‑Based Monitoring (RBM) strategies.
• Review Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and risk logs.
• Identify systemic quality risks and recommend corrective actions.

• Plan, coordinate, or support GCP audits, including investigator site audits, vendor audits, and internal process audits.
• Support preparation for regulatory inspections (FDA, EMA, MHRA, etc.).
• Manage inspection readiness activities, documentation review, and mock inspections.

• Oversee Corrective and Preventive Action (CAPA) processes related to GCP findings.
• Investigate protocol deviations, compliance issues, and audit findings.
• Track CAPA implementation and effectiveness.
• Ensure timely closure of audit observations.

• Provide independent quality oversight of CROs, vendors, and investigative sites.
• Review key trial documents such as protocols, monitoring plans, data management plans, and safety reporting procedures.
• Ensure appropriate sponsor oversight of outsourced activities.

• Develop, review, and maintain clinical SOPs, work instructions, and quality procedures.
• Ensure procedures align with ICH E6(R2)/E6(R3), regulatory requirements, and company quality systems.

• Develop and deliver GCP training programs for clinical teams.
• Ensure training compliance across clinical staff and vendors.
• Provide guidance on GCP interpretation and best practices.

• Ensure compliance with Trial Master File (TMF) requirements.
• Conduct TMF health checks and quality reviews.
• Ensure essential documents are complete, accurate, and inspection‑ready.

• Evaluate CRO and vendor quality systems.
• Participate in vendor qualification and oversight activities.
• Review vendor performance and compliance metrics.

• Ensure compliance with Institutional Review Boards (IRB)/Ethics Committees.
• Ensure compliance with regulatory submissions and approvals.
• Ensure compliance with safety reporting requirements (SAE/SUSAR).

• Identify opportunities to improve clinical processes and quality systems.
• Implement lessons learned and best practices across programs.
• Support quality culture across clinical teams.

• Bachelor’s or advanced degree in life sciences, pharmacy, or medicine.
• 5+ years of experience in quality and clinical development in the pharma space with involvement in regulated clinical trials, clinical safety, and pharmacovigilance.
• Strong knowledge of ICH‑GCP, FDA, EMA regulations.
• Experience with audits, inspections, and quality systems.
• Prior experience with CRO oversight and global trials.
• Advanced degree in life sciences, pharmacy, or medicine preferred.