Manager Laboratory Compliance - Mumbai (Higi)

Responsibilities

• Pharmaceutical Laboratory Compliance & Regulatory Readiness
• Ensure compliance with 21 CFR Parts 210/211, EU GMP (Annex 11 & 15), WHO GMP, ICH Q7/Q9/Q10 , and applicable Pharmacopeia (USP, EP, JP, ChP).
• Act as SME during regulatory inspections (US FDA, EMA) for laboratory equipment, validation, and data integrity.
• Lead inspection preparation activities including gap assessments, mock audits, and documentation readiness .
• Ensure effective handling of audit observations, OOS/OOT investigations, deviations, and CAPAs related to laboratory equipment and systems.
• Data Integrity & Computerized Systems Compliance
• Ensure laboratory compliance with data integrity principles (ALCOA+) across standalone and networked instruments.
• Coordinate validation and compliance of laboratory computerized systems (CDS, LIMS, Empower, standalone software).
• Ensure secure user access, audit trails, backup, archival, and disaster recovery practices.
• Partner with IT and QA to maintain Annex 11 / 21 CFR Part 11 compliance.
• Quality Systems & Documentation
• Establish, review, and approve GMP SOPs related to laboratory equipment use, qualification, calibration, maintenance, and data handling.
• Support method validation, method transfer, and stability programs from an equipment compliance perspective.
• Ensure laboratory practices align with site QMS and J&J Quality standards.
• Stakeholders Management
• Work closely with Quality Assurance, Engineering, IT, Procurement, EHS, and R&D teams.
• Handle third-party service providers for calibration, qualification, and maintenance.
• Team Leadership & Training
• Lead and develop laboratory compliance and equipment specialists.
• Ensure training and qualification of analysts on GMP equipment usage and good documentation practices .
• Drive a strong quality culture and inspection-ready attitude within QC laboratories.
• Continuous Improvement & Risk Management
• Perform risk assessments (FMEA, impact assessments) for equipment failures, data integrity risks, and compliance gaps.
• Drive automation, digital asset management, and paperless initiatives to enhance compliance and efficiency.
• Monitor regulatory trends and proactively update laboratory practices.
• Equipment/Instrument Lifecycle Management:
• Maintain oversight on Calibration and Maintenance Management Program
• Drive automation, digitalization in the field of Equipments/ Instruments lifecycle
• Strengthen compliance and ensure end to end accountability on Equipments/ Instruments lifecycle

Requirements

• Education:
• Bachelor's or master's degree in pharmacy , Pharmaceutical Sciences, Chemistry or Biotechnology
• Experience and Skills:
• Required:
• 10-15+ years in pharmaceutical QC laboratories, equipment lifecycle management, and cGMP compliance, with minimum 2-3 years of Managing/ Leading Team.
• Shown experience with regulatory inspections and agency interactions.
• Strong background in analytical laboratory operations.
• Excellent interpersonal skills including strong verbal and written communication, conflict management and end to

Benefits

Additional Information

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Control Job Category: People Leader All Job Posting Locations: Mumbai, Maharashtra, India Job Description: Manager Laboratory Compliance Job Location - Mumbai (Higi - Mulund) Johnson & Johnson Innovative Medicines is recruiting for a Manager - Laboratory Compliance, located in Mumbai, India. The Laboratory Compliance Manager is responsible for ensuring end-to-end Laboratory Compliance for various processes including non-conformances, CAPA, Change Control, Trainings, Data Integrity, Records Management, Routine cGMP Compliance. The individual shall be responsible for maintaining full compliance with applicable regulatory, quality, and safety standards . This role ensures laboratory operations are inspection-ready, data integrity-compliant, and aligned with global regulatory expectations. Additionally this role would also be responsible for maintaining oversight on Equipment/Instrument Lifecycle Management Activities which include but not limited to, Calibration Program, Maintenance Program, Computerized systems Validations, Periodic Reviews etc.

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