Manager External Quality - Bangalore

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.

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Bangalore, Karnataka, India

Job Description:

Manager External Quality - Bangalore

Johnson & Johnson Innovative Medicines is recruiting for a Manager - External Quality, located in Bengaluru, India.

The Manager External Quality is responsible for providing quality oversight and governance for external manufacturers, suppliers, and service providers to ensure compliance with Johnson & Johnson standards and applicable global regulatory requirements. The individual is accountable for managing quality systems, supplier quality programs, audit management, non-conformance investigations, CAPA effectiveness, change controls, and inspection readiness activities across the external supply network.

This role ensures that externally manufactured products and materials consistently meet quality, safety, efficacy, and regulatory requirements throughout the product lifecycle. The position requires close collaboration with internal cross-functional teams and external partners to proactively identify, assess, and mitigate quality and compliance risks. Additionally, the role is responsible for maintaining oversight of supplier qualification and lifecycle management activities, including quality agreements, risk assessments, performance monitoring, audit programs, regulatory inspections, compliance governance, and continuous improvement initiatives. The Manager - External Quality supports the implementation of robust quality systems and ensures external partners remain inspection-ready and aligned with global quality and regulatory expectations.

 

Responsibilities:

• Oversee manufacturing and packaging operations at external manufacturing sites to ensure compliance with current Good Manufacturing Practices and applicable regulatory expectations.
• Confirm that any testing performed at external manufacturing site laboratories complies with Good Laboratory Practices, approved procedures, and applicable quality requirements.
• Ensure that adequate and effective quality management systems are established, maintained, and followed at external manufacturing sites in alignment with J&J expectations.
• Manage quality issue escalations, investigations, corrections, corrective and preventive actions, and timely closure of quality events.
• Provide quality oversight for quality agreements, product disposition, batch release decisions, product quality complaints, recalls, risk assessments, and change controls.
• Support Sirturo submissions, market launches, and related quality and compliance deliverables.
• Maintain inspection readiness of external manufacturers for regulatory inspections and J&J audits, including representing Janssen during regulatory audits for Sirturo, as applicable.
• Provide quality support for development and lifecycle management projects, including Sirturo paediatric and other assigned initiatives.
• Plan, participate in, and follow up on audits, evaluations, technical visits, and routine quality reviews to ensure agreed actions and objectives are achieved.
• Build effective working relationships with external manufacturers, internal cross-functional partners, and other stakeholders to achieve quality, compliance, and supply objectives.
• Perform related duties as assigned by the supervisor.
• Maintain compliance with all company policies, procedures, and applicable regulatory requirements.

Minimum Qualifications:

• Master of Pharmacy in Pharmaceutics, or an equivalent qualification in Pharmacy or Science.
• Minimum 12+ years of relevant experience in pharmaceutical Quality Assurance, Quality Control, audits, regulatory compliance, external manufacturing, or an equivalent quality function.
• Strong knowledge of current Good Manufacturing Practices, Good Laboratory Practices, pharmaceutical quality systems, and applicable local regulatory requirements.
• Strong knowledge of tablet manufacturing and packaging operations, including process controls, in-process checks, and GMP requirements.
• Excellent verbal and written communication skills, with the ability to communicate effectively with internal and external stakeholders.
• Proficiency in MS Office, SAP, eQMS platforms such as COMET and TrackWise, LIMS, and other applicable quality systems.
• Strong analytical skills to identify gaps, determine root causes, assess risks, and develop practical, compliant solutions.
• Ability to work independently with minimal supervision, manage multiple priorities, meet tight deadlines, and maintain a positive and professional approach.

Other Requirements:

• Ability to build trust and maintain effective relationships with external manufacturers and internal business partners.
• Ability to support regulatory inspections, J&J audits, technical visits, and quality governance reviews.
• Demonstrated sound decision-making, attention to detail, integrity, and accountability in all quality and compliance activities.
• Knowledge of Indian FDA requirements, Schedule M (India), EU-GMP, USFDA, Japanese GMP, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, and regulatory approvals from the Republic of Kenya, Uganda, Turkey, and Saudi FDA is preferred.

 

 

Required Skills:

 

 

Preferred Skills:

Business Alignment, Coaching, Collaboration, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility