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Manager – R&D Quality Gcp Qa

Sun Pharma
Sun Pharma
10+ years
preferred by company
Vadodara, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Job Title: Manager – R&D Quality GCP QA

Location: Vadodara, Gujarat, India
Job Type: Full-Time
Experience Required: 10+ Years (Freshers are not eligible)
Industry: Clinical Quality Assurance / Pharmaceuticals / Clinical Research / Drug Development / Life Sciences
Department: R&D Quality / Good Clinical Practice (GCP) Quality Assurance

About the Role
We are seeking a highly experienced and quality-focused Manager – R&D Quality GCP QA to lead Good Clinical Practice (GCP) quality assurance oversight across in-house and outsourced clinical research programs. This senior-level opportunity is ideal for professionals with deep expertise in clinical quality assurance, GCP audits, CRO oversight, regulatory inspections, CAPA governance, and pharmaceutical R&D quality systems.

The ideal candidate will drive clinical quality excellence, strengthen GCP compliance frameworks, oversee outsourced study quality governance, and support inspection readiness across clinical development operations.

This opportunity is highly suited for experienced clinical QA leaders with strong pharmaceutical research and audit expertise.

Key Responsibilities

GCP Quality Assurance & Quality Systems Management

  • Develop, review, coordinate, and implement Quality Assurance (QA) SOPs, Global Quality Systems (GQS), and GCP governance frameworks in collaboration with R&D stakeholders.
  • Evaluate current clinical quality systems and identify opportunities for compliance improvement, process harmonization, and operational excellence.
  • Strengthen enterprise-wide clinical quality assurance practices across in-house and outsourced research activities.
  • Ensure adherence to Good Documentation Practices (GDP), internal quality policies, and applicable regulatory requirements.

Clinical Audits & GCP Compliance Oversight

  • Lead and conduct GCP audits for outsourced BA/BE studies involving healthy volunteer and patient-based clinical research.
  • Perform investigator site audits, site selection audits, Trial Master File (TMF) audits, retrospective study documentation audits, in-process audits, and compliance reviews.
  • Assess trial conduct, documentation integrity, protocol adherence, and regulatory compliance across clinical operations.
  • Identify compliance gaps, operational risks, and quality improvement opportunities.

CRO / Vendor Qualification & Oversight

  • Conduct qualification and requalification audits for Contract Research Organizations (CROs), Contract Service Providers (CSPs), and relevant external vendors.
  • Evaluate vendor compliance against contractual expectations, GCP requirements, quality standards, and operational readiness criteria.
  • Support quality oversight of outsourced research partnerships and third-party service delivery.

CAPA Management & Quality Risk Resolution

  • Review, assess, and verify adequacy, implementation, and effectiveness of Corrective and Preventive Actions (CAPA) arising from audits, inspections, compliance findings, and corporate quality reviews.
  • Ensure root cause investigations are robust, sustainable, and aligned with regulatory expectations.
  • Monitor remediation effectiveness and support closure of quality observations.

Study Documentation & Clinical QA Review

  • Provide GCP QA oversight for creation and review of study protocols, study plans, investigator brochures, informed consent forms (ICFs), clinical study reports, and related documentation.
  • Ensure clinical study documentation aligns with applicable regulations, internal standards, and documentation quality expectations.
  • Support document governance for both internal and outsourced clinical studies.

Regulatory Inspection Support & Compliance Management

  • Support preparation, coordination, and execution of regulatory inspections involving clinical development programs.
  • Collaborate with R&D stakeholders on regulatory response preparation, compliance remediation, and issue resolution.
  • Assist with regulatory query review and submission support as required.
  • Ensure inspection readiness across clinical quality and operational functions.

Training, Leadership & Quality Culture Development

  • Mentor direct and indirect team members through coaching, structured performance feedback, capability development, and quality leadership.
  • Support training initiatives related to GCP compliance, QA expectations, audit readiness, and regulatory quality standards.
  • Promote a strong culture of compliance, accountability, and continuous improvement across teams.

Regulatory Intelligence & Continuous Improvement

  • Monitor changes in local and international GCP regulations, regulatory guidelines, and clinical quality standards.
  • Advise internal stakeholders on evolving compliance expectations and operational implementation requirements.
  • Drive quality transformation initiatives, process harmonization, and continuous quality system enhancement.

Required Qualifications

  • Graduate or postgraduate degree in Life Sciences, Pharmacy, Biomedical Sciences, Clinical Research, Basic Sciences, or related healthcare disciplines.
  • 10+ years of relevant GCP clinical research experience, including at least 6 years in Quality Assurance (QA) environments.
  • Strong expertise in ICH-GCP, global clinical regulations, QA governance, outsourced study oversight, audit management, and inspection readiness.
  • Proven experience conducting internal and external GCP audits, CRO/vendor qualification audits, and regulatory compliance reviews.
  • Experience handling regulatory agency inspections and quality remediation programs.
  • Strong knowledge of CAPA management, quality systems, risk assessment, and sponsor oversight frameworks.
  • Proficiency in IT systems, documentation tools, and quality governance processes.
  • Excellent communication, leadership, stakeholder management, and independent decision-making skills.