Sr Clinical Quality Specialist

7-10 years

Not Disclosed

Mumbai

10 Sept. 30, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🌐 Position: Sr. Clinical Quality Specialist

Location: Mumbai, Maharashtra
Job Type: Full-Time | Regular
Job ID: R0149428
Date Posted: September 24, 2025
Company: Takeda Pharmaceuticals
Travel: Up to 30% (Domestic)

🧭 Objective / Purpose

Oversee and manage Clinical Quality functions in compliance with local regulatory requirements and Takeda’s Global Quality Management System (QMS).
Collaborate closely with local clinical operations teams to ensure adherence to Good Clinical Practice (GCP).
Drive continuous improvement and quality excellence in all clinical trial activities within India.

🎯 Key Accountabilities

1. Quality Systems & Process Development

Develop and implement Clinical Quality Assurance (CQA) procedures and local QMS for managing clinical trial quality.
Serve as cross-functional reviewer and quality authorizer per internal procedures.
Maintain and monitor local risk register and engage stakeholders to identify, mitigate, and monitor GxP risks (focus on GCP).
Ensure local Quality Council meetings are conducted regularly with performance metrics and supplier quality reports.

2. Audit & Compliance Oversight

Lead and conduct supplier and clinical study audits (internal and external, including site audits).
Provide independent GCP compliance oversight for suppliers, including Quality Agreements and Governance meetings.
Initiate Quality Incident Notifications and escalation reports for notifiable events per Takeda’s procedures.
Evaluate audit findings, assess compliance risks, and escalate critical findings promptly.
Support deviation/incident management for critical or major trial deviations and approve CAPAs as needed.

3. QMS Maintenance & KPI Management

Maintain local Quality Management System (QMS) and ensure all KPIs are achieved.
Oversee QMS elements such as:
- Change Control
- Deviations
- CAPA
- Complaints
- Risk Mitigation
- Gap Assessments
Support PV & RA quality reviews and gap assessments for GxP compliance.

4. GCP Guidance & Clinical Support

Provide GCP guidance to clinical teams on day-to-day operations.
Review and approve critical clinical study documents (e.g., protocols).
Guide Clinical Operations, Clinical Supply, Regulatory Affairs, and Suppliers on compliance, quality oversight, and governance.
Support root cause analysis and CAPA implementation for identified issues.

5. Inspection & Regulatory Support

Provide support during self-inspections, internal audits, supplier audits, and regulatory inspections.
Liaise with local regulatory authorities for GCP-related inspections and ensure timely completion of commitments.
Manage regulatory communications and inspection readiness at the LOC level.

6. Pharmacovigilance Vendor Oversight

Conduct risk assessment of local GPvP vendors and develop corresponding audit plans.
Execute Local GPvP Vendor Audit Plan and manage outsourced audits conducted by consultants.

7. Training Management

Maintain training programs for local quality procedures in Takeda’s LMS.
Assign training to targeted GxP audiences and act as system training administrator.

🧠 Dimensions & Aspects

⚙️ Technical / Functional Expertise

Strong knowledge of pharma industry regulations, local clinical trial guidelines, and ICH guidelines (E3, E6, E8, E9).
Excellent understanding of cGxPs, quality standards, and industry best practices.

👥 Leadership

Collaborate effectively with cross-functional stakeholders.
Demonstrate organizational agility and the ability to lead change.
Manage multiple priorities and shift focus as needed.
Drive a high-performance culture to achieve results.

🧭 Decision-Making & Autonomy

Anticipate and address quality system challenges and regulatory expectations.
Assess potential impacts and implement compliant, risk-based solutions.

🔄 Interaction

Internal: Collaborate with local stakeholders across functions to address business and compliance needs.
External: Maintain productive relationships with CRO partners and regulatory bodies to ensure quality standards.

💡 Innovation

Stay informed on local industry, scientific, and regulatory trends.
Apply innovative approaches to quality improvement and compliance management.

🧩 Complexity

Manage multiple CROs, navigate a diverse regulatory framework, and oversee a broad product portfolio.

🎓 Education & Experience

Qualification: Graduate/Postgraduate in Life Sciences.
Experience: 7–10 years in clinical trial industry with expertise in Clinical Quality Auditing.
Proven ability to work independently, identify compliance risks, and escalate when required.
Strong sense of urgency, accountability, and problem-solving mindset.

🧩 Core Competencies / Skills

Critical Thinking & Root Cause Analysis
Risk Identification & Management
Strong Communication & Stakeholder Management
Influencing & Negotiation Skills
Teamwork & Coordination
Agility & Prioritization
Investigation & Problem Solving

🚀 Leadership Behaviors

Foster enterprise thinking and patient-centered innovation.
Create an inspiring and enabling environment.
Focus on key priorities to deliver superior results.
Build and elevate team capabilities for current and future success.

✈️ Travel Requirements

Domestic travel: Up to 30%

📍 Work Details

Location: Mumbai, India
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full-Time

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Sr Clinical Quality Specialist

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