GCP Manager (Quality & Compliance) at Zydus Therapeutics Inc. – Pennington, New Jersey

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 is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow.

RESPONSIBILITIES:

GCP Compliance Oversight

· 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.

Quality Management & Risk Oversight

· 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.

Audit & Inspection Readiness

· Plan, coordinate, or support GCP audits including:

o Investigator site audits

o Vendor audits

o Internal process audits

· Support preparation for regulatory inspections (FDA, EMA, MHRA, etc.).

· Manage inspection readiness activities, documentation review, and mock inspections.

CAPA Management

· 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.

Clinical Trial Oversight

· Provide independent quality oversight of CROs, vendors, and investigative sites.

· Review key trial documents including:

o Protocols

o Monitoring plans

o Data management plans

o Safety reporting procedures

· Ensure appropriate sponsor oversight of outsourced activities.

(For outsourced projects)

SOP Development and Maintenance

· Develop, review, and maintain clinical SOPs, work instructions, and quality procedures.

· Ensure procedures align with:

o ICH E6(R2)/E6(R3)

o Regulatory requirements

o Company quality systems.

Training and GCP Education

· 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.

TMF and Documentation Compliance

· Ensure compliance with Trial Master File (TMF) requirements.

· Conduct TMF health checks and quality reviews.

· Ensure essential documents are complete, accurate, and inspection ready.

Vendor and CRO Oversight

· Evaluate CRO and vendor quality systems.

· Participate in vendor qualification and oversight activities.

· Review vendor performance and compliance metrics.

Regulatory & Ethical Compliance

· Ensure compliance with:

o Institutional Review Boards (IRB)/Ethics Committees

o Regulatory submissions and approvals

o Safety reporting requirements (SAE/SUSAR).

Continuous Improvement

· Identify opportunities to improve clinical processes and quality systems.

· Implement lessons learned and best practices across programs.

· Support quality culture across clinical teams.

QUALIFICATIONS

Bachelors or Advanced degree in life sciences, pharmacy, or medicine.

5+ years of experience in quality and clinical development in pharma space with involvement in regulated clinical trials, clinical safety, pharmacovigilance.

Strong knowledge of ICH-GCP, FDA, EMA regulations.

Experience with audits, inspections, and quality systems.

Prior experience with CRO oversight and global trials.

EDUCATION & EXPERIENCE:

Advanced degree in life sciences, pharmacy, or medicine preferred.