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Site Quality Head

20+ years
Not Disclosed
1 June 28, 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

Location: Not Specified
Role: Site Quality Head
Company: Not Specified

Qualification:

  • Graduate in Science or Pharmacy (or equivalent)

Experience:

  • Minimum 20+ years in pharmaceutical quality management

  • Preference for candidates currently holding similar leadership roles in QA/QC

Position Summary:
The Site Quality Head is accountable for ensuring the supply of high-quality, GMP-compliant pharmaceutical products from the site. The role involves defining and executing the operational quality strategy for the site in line with Sun Pharma’s compliance, product quality goals, and global regulatory expectations.

This individual provides leadership across Quality Assurance (QA), Quality Control (QC), and Stability operations at the site. The role requires proactive issue identification, implementation of effective quality systems, and assurance of audit readiness at all times. The incumbent must also ensure compliance with all regulatory requirements, GxP standards, documentation practices, training systems, SOPs, and Sun Pharma’s global quality policies.

Key Responsibilities:

  • Assess and address quality issues at the site while ensuring full compliance with QA/QC regulatory standards in manufacturing operations.

  • Track quality metrics across site operations and work collaboratively with site manufacturing teams to reduce deviations.

  • Design, implement, and enforce compliance with all site-level SOPs, policies, standards, and quality systems.

  • Drive continuous improvement initiatives to enhance regulatory compliance, process efficiency, and cost-effectiveness.

  • Ensure adequate manpower and resources are available for sustained GxP compliance.

  • Harmonize and implement global quality systems and procedures in alignment with corporate standards.

  • Investigate and resolve market complaints, batch failures, and deviations, ensuring timely implementation of CAPA.

  • Maintain constant audit readiness for regulatory inspections and internal audits.

  • Monitor industry developments and internal quality challenges to proactively upgrade site quality management practices.

  • Ensure compliance with all product, process, and release-related regulatory requirements.

  • Oversee budget planning for quality-related revenue, capital expenses, and manpower; manage resources within allocated limits.

  • Guarantee the release of safe and effective drug products from the site as per cGMP and regulatory requirements.

  • Promote smooth cross-functional collaboration with other Sun Pharma sites to create operational synergies.

  • Ensure adherence to EHS policies, laboratory SOPs, and maintain consistent GMP compliance.

Estimated Salary: ₹70 – ₹100 LPA (depending on site scale, regulatory exposure, and organizational size)