Research Development Quality And Risk Management Inspection Management Lead (All Genders)

8+ years

Not Disclosed

Mumbai

10 Feb. 5, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Inspection Management Lead – Research Development Quality & Risk Management

Job ID: 280439 | Location: Mumbai, Maharashtra, India
Job Type: Full-time

About the Role:

As an Inspection Management Lead, you will play a crucial role in ensuring compliance with GCP, GLP, and GVP regulations by coordinating Health Authority inspections for Healthcare R&D projects and facilities. You will lead inspection readiness strategies, collaborate with regulatory bodies, and oversee the quality assurance processes to maintain the highest industry standards.

Key Responsibilities:

Inspection Management:
- Coordinate preparation, execution, and close-out of Health Authority inspections.
- Establish communication channels with regulatory inspectors and manage pre-inspection requests.
- Host inspections and provide full operational support during audits.
- Lead response teams for inspection findings, ensuring timely follow-ups and corrective actions.
Inspection Readiness & Quality Assurance:
- Develop and maintain inspection readiness strategies across Healthcare R&D.
- Track and ensure completion of Corrective and Preventive Actions (CAPA) for inspectional observations.
- Conduct mock inspections to prepare for regulatory audits.
- Maintain an effective inspection communication process within the organization.
Regulatory Compliance & Risk Management:
- Stay updated on evolving regulatory inspection trends (e.g., MHRA, FDA, EMA, PMDA).
- Ensure compliance with international regulations and guidelines in drug development.
- Assess and manage potential quality risks and implement mitigation strategies.
- Collaborate with cross-functional teams to develop Quality Management Systems (QMS).

Qualifications & Experience:

Education: Bachelor’s degree in scientific or quality-related subjects (Advanced degree preferred).
Experience:
- 8+ years in Quality Assurance (QA) or related roles in pharmaceutical/biotech industry.
- 5+ years in Clinical QA, with experience in clinical development and regulatory compliance.
- Regulatory Authority inspection experience with agencies like FDA, EMA, MHRA, PMDA.
- Strong knowledge of GCP, GLP, GVP (with basic understanding of GMP, GDP).
- Experience in oncology, biotherapeutics, biosimilars, and emerging markets is a plus.

Skills & Competencies:

Strong leadership and team coordination skills.
Excellent negotiation, problem-solving, and strategic thinking abilities.
High attention to detail while maintaining a business-oriented approach.
Ability to adapt to change and work under high-pressure inspection conditions.
Fluency in written and spoken English.

Why Join Us?

Be part of an inclusive and diverse global team.
Work on cutting-edge drug development and healthcare innovations.
Career growth opportunities in Quality Assurance and Risk Management.
Contribute to shaping industry-leading compliance strategies.

Apply now and ensure the highest standards in regulatory compliance!

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Research Development Quality And Risk Management Inspection Management Lead (All Genders)

Job Description

Inspection Management Lead – Research Development Quality & Risk Management

About the Role:

Key Responsibilities:

Qualifications & Experience:

Skills & Competencies:

Why Join Us?

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