GCP Manager (Quality & Compliance) at Zydus Therapeutics Inc.

Hopewell Township, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Jun, 26

Salary

0.0

Posted On

27 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GCP Compliance, Quality Management Systems, Risk-Based Quality Management, Risk-Based Monitoring, Audits, Inspection Readiness, CAPA Management, CRO Oversight, SOP Development, GCP Training, TMF Compliance, ICH-GCP, FDA Regulations, EMA Regulations, Clinical Trials, Quality Oversight

Industry

Pharmaceutical Manufacturing

Description

Description 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: Investigator site audits Vendor audits 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: Protocols Monitoring plans Data management plans 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: ICH E6(R2)/E6(R3) Regulatory requirements 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: Institutional Review Boards (IRB)/Ethics Committees Regulatory submissions and approvals 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. Requirements QUALIFICATIONS – SKILLS & REQUIREMENTS: 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, pharmcovigilance. 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. TRAVEL: >10%

Responsibilities

The role involves ensuring all clinical trials adhere to ICH-GCP, regulatory requirements, and sponsor SOPs through GCP compliance oversight across all trial phases globally. Key duties include developing Quality Management Systems, managing audits and inspections, overseeing Corrective and Preventive Action (CAPA) processes, and providing quality oversight of CROs and vendors.