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Compliance Head

15+ years
₹50 – ₹70 LPA
10 June 28, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm 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
Company: Not Specified
Position: Senior Manager – Compliance Head
Job Grade: G9A
Job Title: Senior Manager, Compliance
Function: Quality Assurance (QA)
Sub-function: Compliance
Number of Direct Reports: Not Specified

Qualification:

  • B.Pharm / M.Pharm

Experience:

  • Minimum 15 years of experience in pharmaceutical compliance

  • Mandatory experience with USFDA/EU regulated market business sites

Job Summary:
The Senior Manager – Compliance Head is responsible for ensuring site-wide adherence to regulatory, corporate, and quality system requirements. This includes overseeing in-process controls for both sterile and non-sterile operations, managing validation and qualification programs, and leading site-level QMS activities. The role demands excellent audit preparedness, electronic documentation management expertise, and strong leadership to drive a culture of continuous compliance.

Key Responsibilities:

  • Ensure robust knowledge and application of global regulatory guidelines across site operations.

  • Supervise and support in-process quality control on the shop floor for both sterile and non-sterile operations.

  • Lead and oversee validation and qualification of equipment, instruments, and software in line with current regulatory standards.

  • Manage and monitor Quality Management System (QMS) activities, including deviations, CAPA, change controls, and documentation.

  • Drive and lead self-inspections, ensuring thorough monitoring and timely closure of all CAPA.

  • Ensure strong familiarity and implementation of software-based QMS, electronic controls, and secure data management practices.

  • Host external regulatory audits (e.g., USFDA, MHRA, EU), demonstrating excellent communication, documentation control, and cross-functional coordination.

  • Lead compliance initiatives across the site by working closely with cross-functional teams and promoting a quality-first mindset.

  • Maintain high audit readiness and ensure effective communication with regulators, internal teams, and auditors.

  • Collaborate and guide team members to collectively uphold compliance standards and promote harmony in execution.

  • Actively contribute to strategic site quality improvements by integrating compliance findings and industry best practices.

Skills & Attributes:

  • Strong knowledge of regulatory compliance, cGMP, and QMS systems

  • Hands-on experience in audit hosting and inspection readiness

  • Proficiency in validation/qualification lifecycle for equipment and software

  • Excellent verbal and written communication skills (especially in English)

  • Proficiency in electronic quality management systems

  • Team leadership and cross-functional collaboration

  • Strong problem-solving and auditing capabilities

  • Self-motivated, detail-oriented, and process-driven

Estimated Salary: ₹50 – ₹70 LPA (depending on site complexity, regulatory exposure, and audit experience)