ãConsumerãSource Quality Manager_External Manufacturing
ãConsumerãSource Quality Manager_External Manufacturing
Posted on :
22-08-2025
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1 Vacancy
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Job Description
Key measures:
This position will be measured primarily on:
- Adherence to J&J guidelines and achieving targets set for External Manufactures (EMs).
- Strategies identification/ implementation for timely uninterrupted and defect free product supply to the market from the EMs.
- Compliance to regional/global Strategic Initiatives and proactive closure of gaps within the cluster.
- Identification development and retention of critical talent within the team.
Position Description:
Responsiblefor overall quality oversight and governance of External Manufacturers and position will focus on ensuring compliance with applicable regulationsdriving and implementing Companys Quality policies and standards achieving therequired business results. The position requires focus on people developmentand talent attraction/ retention initiatives. The position requires closecoordination with business stakeholders such as Supply Chain Sourcing Operations SMP R&D RegulatoryAffairs HR and Franchise/SFO organizations to ensure business & compliancegoals meets with expected J&J and regulatory standards.
- Champion the creation and maintenance of Credo-based environment inhis area of responsibility living Credo values building trust and caring forpeople.
- Provide leadership to achieve Quality & Compliance objectiveslaid down for External Manufacturers and Suppliers in line with Strategic plansaligned with the Management with customer focus.
- Ensure the external manufacturing sites assess Quality systems effectivelythrough internal audit and Management review and implement corrective/preventive improvement actions as appropriate.
- Support manufacturing sites in the investigation evaluation andimplementation of actions to eliminate root causes of non-conformances.
- Establish and monitors metrics for the measurement of Qualityindicators and Quality Costs to ensure effectiveness and value to the business.
- Provide disposition for non-compliant products and assuresescalation of potential quality or compliance problems to regional leader.
- Ensure effective risk management processes are implemented toprevent unanticipated failure modes.
- Liaise with the Complaint Vigilance and External manufacturing sitesto improve the customer experience through proactive management of the manufacturing sites address all customer feedbacks and complaint inappropriate and timely manner.
- Enable product localizations/New product launches to deliver marketappropriate product offerings.
- Ensure quality processes are followed across the external network byenforcing Quality Agreements establishing product specifications and deployingquality assurance procedures meeting J&J requirements. Ensure external partners remains compliant tohealth authority regulations and other country statutory requirements.
- Ensure defect free and timely product supply to the market. EstablishGovernance strategies along with EM make/ source Procurement Planning supplychain and Franchise colleagues to ensure that external partners and sourcinglocations continued to remain compliant agile and flexible to deliver qualityproducts per business needs. Quality events and issues are resolved speedilyand through cross functional collaboration as deemed necessary.
- Lead people development objectives and support programs to ensureavailability of competent people and talent retention. Ensure opportunities anddevelopmental programs are consistently provided to deserving candidates.
- Support annual budget and BP planning exercise for the clustermanaged.
- Cascade global strategic initiatives and drive deployment of Globalstandards to the External network for EMs/Suppliers. Ensure adequate gapassessments have been conducted and gaps are closed with definite timelines.
- Manage the process for reporting key KPIs by collecting analyzingand summarizing information and trends including improvements expected withExternal partners and align proactive remediation plans in accordance withbusiness risks.
- This individual has the necessary independence authority andresponsibility to initiate action to prevent nonconformities enact remediationplans identify and document quality problems initiate recommend provide andverify solutions to quality problems and direct or control further processingand delivery of nonconforming product sourced from External Manufactures.
- At a minimum a Bachelors degree or equivalent in Pharma / Chemistry/Life Science or Engineering.
- Ten (10) years related experience in Pharmaceutical Industry in Quality Management.
- About 3-4 years of active management experience including direct supervision.
- Experience with Japan HA compliance and inspections.
- Fluency in English-both Written/Verbal.
- Good Communication and Presentation Skills.
- Project Management.
- Business Acumen
- Systems Development and Integration.
Other Abilities/Qualities
- Self-directed Working
- Analytical Thinking and Decision making
- Influencing Collaboration and Teaming
- Self-awareness and Adaptability
- Talent Development
- Results and Performance drive
- Sense of Urgency.
Employment Type
Intern
Key Skills
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