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Compliance Head

15+ years
Not Disclosed
10 Jan. 31, 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

📌 Senior Manager – Compliance Head | [Company Name] | Location: [Insert Location]

📍 Location: [Insert Location]
💼 Company: [Insert Company Name]
🕒 Experience: 15+ years in regulatory compliance and quality assurance

Position Summary

The Senior Manager – Compliance Head will be responsible for overseeing the regulatory compliance and quality management systems (QMS) at the site. The role requires extensive knowledge in regulatory guidelines, validation, equipment qualification, and handling of inspections, while ensuring the site adheres to industry standards and regulatory requirements.

Key Responsibilities

Regulatory Guidelines & Compliance: Ensure the site is in full compliance with regulatory guidelines for both non-sterile and sterile operations.
QMS Management: Handle all Quality Management System (QMS) activities, ensuring proper documentation and adherence to industry standards.
Validation & Qualification: Oversee the validation and qualification of equipment, instruments, and software, ensuring compliance with cGMP standards.
CAPA Management: Drive the Corrective and Preventive Actions (CAPA) process, ensuring that corrective actions are tracked and closed effectively.
Audit Readiness: Host external audits and ensure the site is always prepared for inspections. Serve as the key point of contact during USFDA/EU inspections.
Team Leadership: Lead the compliance efforts across the site, fostering a culture of teamwork and collective effort.
Continuous Improvement: Proactively identify opportunities to improve compliance processes and ensure the site maintains audit readiness.

Job Requirements

🎓 Education:

  • B. Pharm/M. Pharma

💼 Experience:

  • 15+ years of experience in regulatory compliance and quality assurance within the USFDA/EU regulated market.
  • Experience in In-process control for both non-sterile and sterile operations.

💡 Skills & Knowledge:

  • Strong knowledge of QMS systems, auditing skills, and regulatory guidelines.
  • Experience with software-based QMS and electronic controls for data management.
  • Strong leadership and team management skills, with the ability to host audits and maintain regulatory compliance at the site.

Desired Skills

  • Fluent spoken English and ability to interact with different stakeholders, especially during inspections.
  • A self-motivated leader with a collaborative mindset to drive compliance efforts.

Work Conditions

  • Full-time position
  • Location: [Insert Location]

📩 Apply Now