Manager Laboratory Compliance - Mumbai (Higi)

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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.

• 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.

• 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.

• 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.

• Work closely with Quality Assurance, Engineering, IT, Procurement, EHS, and R&D teams.
• Handle third-party service providers for calibration, qualification, and maintenance.

• 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.

• 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.

7. 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

Education:

• Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Chemistry or Biotechnology

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 end mindset.

• Experience in US FDA & EMA Inspection handling

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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