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)
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