Executive -Make Q&C (Selfcare)

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Executive – Make Quality (Selfcare)

Location: Mumbai, India
Function: Quality Assurance / External Manufacturing Quality
Reporting To: General Manager – Quality & Compliance

Who We Are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we are the house of iconic brands such as NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID®. Our global team of 22,000+ people is passionate about insights, innovation, and delivering the best products to consumers worldwide. Being a Kenvuer means having the opportunity to positively impact millions of lives every day through science, care, and courage.

What You Will Do

The Executive – Make Quality (External Manufacturing) will be responsible for ensuring consistent product quality, regulatory compliance, and uninterrupted supply from external manufacturing partners (CMOs/TPMs) supporting India and export markets. This role focuses on GMP compliance, Quality Management System (QMS) effectiveness, batch release readiness, and continuous improvement across the external manufacturing network.

Key Responsibilities

External Manufacturing Oversight

• Act as the primary Quality point of contact for assigned CMOs and ensure compliance with Quality Agreements.
• Monitor CMO performance metrics including Right-First-Time (RFT), deviations, CAPA effectiveness, OOS/OOE trends, complaints, and on-time delivery.
• Support technology transfers, scale-ups, validations (process, cleaning, analytical), and change management activities.

Batch & Product Quality

• Review and approve batch manufacturing records, deviations, CAPAs, and change controls in line with QMS requirements.
• Ensure timely batch disposition including batch release readiness, CoA verification, serialization/aggregation compliance (where applicable), and artwork/version control.
• Lead Product Quality Reviews (PQR/APR), perform trend analysis, and drive improvement actions with CMOs.

Compliance & Audits

• Ensure compliance with applicable GMP regulations for India and export markets (Schedule M, CDSCO/State FDA, WHO GMP, ICH Q10/Q7, PIC/S, and country-specific requirements).
• Plan, conduct, and support CMO audits (qualification, routine, and for-cause) and ensure timely closure of audit observations.
• Support regulatory and customer inspections, including preparation of responses and remediation plans.

Quality Systems & Risk Management

• Strengthen QMS implementation at CMOs including document control, training, deviations/CAPA, change control, complaints, recalls, supplier qualification, and data integrity.
• Lead Quality Risk Management activities (FMEA, HACCP) for products, processes, and supply chain risks.
• Ensure ALCOA+ data integrity principles are followed across manufacturing, testing, and release documentation.

Supply Continuity & Governance

• Partner with Supply Chain, Manufacturing, Regulatory Affairs, and Procurement teams to ensure uninterrupted and compliant supply.
• Participate in S&OP discussions and CMO governance meetings; manage quality issue escalation as required.
• Drive continuous improvement initiatives to improve RFT, reduce cycle time, enhance yields, and reduce Cost of Poor Quality (COPQ).

Documentation & Reporting

• Maintain dashboards and monthly quality metrics for assigned CMOs.
• Prepare management updates, investigation summaries, and provide support for regulatory submissions as required.

Technical Competencies

• Strong technical understanding of GMP, quality systems, and external manufacturing quality management.
• Hands-on experience with QMS processes including deviation management, CAPA, change control, and batch record review.
• Knowledge of process, cleaning, and analytical validation activities.
• Strong data integrity and documentation practices aligned with ALCOA+ principles.
• Proficiency in MS Office tools (Excel, PowerPoint) and familiarity with eQMS/LIMS/ERP systems.

Leadership & Behavioral Competencies

• Ability to assertively enforce quality standards and Quality Agreements at CMOs.
• Strong analytical and risk-based thinking with effective root cause analysis skills (5-Why, Fishbone, FMEA).
• Effective cross-functional collaboration and stakeholder management skills.
• Clear written and verbal communication with strong reporting capabilities.
• Proactive problem-solving mindset with a bias for action and continuous improvement.

What We Are Looking For

Education & Experience

• Education: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry, Biotechnology, or equivalent).
• Experience: 6–8 years of experience in QA/QC/Manufacturing within pharma, biotech, or consumer health industries, including a minimum of 2 years managing external manufacturing or supplier quality.
• Regulatory Exposure: Strong understanding of GMP, Schedule M, WHO GMP, ICH Q10, data integrity, and export market requirements (GCC, ASEAN, Africa, LATAM; EU/US exposure is an added advantage).

Key Performance Indicators (KPIs)

• On-time, in-full (OTIF) batch release from CMOs
• Right-First-Time (RFT) performance and deviation/CAPA cycle time
• Audit performance and on-time closure of findings
• Complaint rate and investigation closure timelines
• Change control effectiveness
• PQR/APR completion and action closure
• Reduction in Cost of Poor Quality (COPQ)
• Regulatory inspection readiness with zero critical observations

Travel Requirement

20–40% (Domestic travel; occasional international travel based on CMO locations and market requirements)

Employment Type

Full-time

Kenvue is an Affirmative Action and 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, or veteran status.

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