Manager - Central Quality Assurance (Vendor Management & Compliance)

ACG; Mumbai; Sur place; INR 1 400 000 - 2 000 000; Plein temps

Résumé du poste

ACG Capsules in Kandivali, Mumbai seeks a Manager - Central Quality Assurance (Vendor Management & Compliance) to lead and govern vendor management and compliance across sites. The role focuses on strengthening QMS, audit readiness, and regulatory adherence, including FDA activities and global certifications.

You will drive cross-functional alignment with Procurement, Regulatory, Operations and Quality teams, and lead CAPA and root cause analyses to ensure continuous quality improvement and risk

Responsabilités

• Define and drive vendor management strategy to ensure availability of qualified and compliant vendors
• Establish governance framework for vendor qualification, performance monitoring, and requalification
• Drive standardisation of vendor management across sites
• Lead audit readiness strategy for internal, external, and regulatory audits
• Identify risks in vendor quality and compliance systems and implement mitigation plans
• Drive digitalisation and process improvement initiatives in vendor management and DMS
• Oversee vendor qualification, evaluation, and approval processes in alignment with regulatory and internal standards
• Review and approve vendor specifications in alignment with ACG quality requirements
• Ensure effective management of vendor documentation and compliance through systems/portals
• Review and approve SOPs related to vendor management and QMS
• Ensure readiness and compliance of raw material and packaging material specifications
• Oversee planning and execution of vendor audits and internal audits across sites
• Own end-to-end vendor compliance and QMS performance across ACG Capsules
• Drive cross-functional alignment with Procurement, Regulatory, Operations, and Quality teams
• Lead root cause analysis for critical deviations, audit observations, and vendor-related issues
• Drive implementation of preventive and corrective actions for vendor complaints to strengthen quality systems
• Establish performance metrics for vendor quality and audit outcomes
• Act as escalation point for critical vendor and compliance-related issues
• Own and monitor regulatory and certification compliance across applicable India and overseas locations, including FDA activities, ISO, EXCiPACT, FSSAI, FDS and other relevant requirements.
• Ensure timely renewal and maintenance of manufacturing licences, regulatory approvals and applicable quality certifications to support uninterrupted compliant operations.

Description du poste

Position Title: Manager - Central Quality Assurance (Vendor Management & Compliance), ACG Capsules

Organization Context

Position Title:

Manager - Central Quality Assurance (Vendor Management & Compliance), ACG Capsules

Employee Name:

Grade:

M05 or M06

Department:

Quality and Regulatory Affairs

Location:

Kandivali

Reports to:

Head - Central Quality Assurance, ACG Capsules

Reported by:

2 - Sr. Executives

ACG is the world s only integrated pharma manufacturing solutions company. We are headquartered in Mumbai, India. ACG has a presence in over 100 countries with its products and services that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems.

We have an opportunity in ACG Capsules of a Manager - Vendor Management & Compliance, Central Quality Assurance, Quality and Regulatory Affairs.

Job Objective

• To lead and govern vendor management and compliance processes across ACG Capsules, ensuring a robust and compliant vendor base.
• Drive Quality Management Systems (QMS) while strengthening audit readiness, regulatory compliance, and continuous improvement across sites.

Primary responsibilities

Strategy & Planning

• Define and drive vendor management strategy to ensure availability of qualified and compliant vendors
• Establish governance framework for vendor qualification, performance monitoring, and requalification
• Drive standardisation of vendor management across sites
• Lead audit readiness strategy for internal, external, and regulatory audits
• Identify risks in vendor quality and compliance systems and implement mitigation plans
• Drive digitalisation and process improvement initiatives in vendor management and DMS

Functional

• Oversee vendor qualification, evaluation, and approval processes in alignment with regulatory and internal standards
• Review and approve vendor specifications in alignment with ACG quality requirements
• Ensure effective management of vendor documentation and compliance through systems/portals
• Review and approve SOPs related to vendor management and QMS
• Ensure readiness and compliance of raw material and packaging material specifications
• Oversee planning and execution of vendor audits and internal audits across sites

Core

• Own end-to-end vendor compliance and QMS performance across ACG Capsules
• Drive cross-functional alignment with Procurement, Regulatory, Operations, and Quality teams
• Lead root cause analysis for critical deviations, audit observations, and vendor-related issues
• Drive implementation of preventive and corrective actions for vendor complaints to strengthen quality systems
• Establish performance metrics for vendor quality and audit outcomes
• Act as escalation point for critical vendor and compliance-related issues
• Own and monitor regulatory and certification compliance across applicable India and overseas locations, including FDA activities, ISO, EXCiPACT, FSSAI, FDS and other relevant requirements.
• Ensure timely renewal and maintenance of manufacturing licences, regulatory approvals and applicable quality certifications to support uninterrupted compliant operations.

People Development

• Lead and develop the vendor management and QMS team
• Drive capability building on GxP practices, audit readiness, and regulatory compliance
• Build a culture of quality, compliance, and continuous improvement across teams

Regulatory & Certification Compliance

• Ensure compliance with applicable FDA, FSSAI, FDS and other regulatory requirements across India and overseas locations.
• Ensure timely completion of FDA activities, regulatory audits and inspections wherever required.
• Ensure valid manufacturing licences, regulatory approvals and certifications are maintained.
• Oversee applicable ISO, EXCiPACT and other quality certifications for India and overseas locations.
• Ensure timely closure of regulatory and certification-related observations and CAPAs.

Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.

Key Result Areas

• Vendor compliance and approval cycle time
• Audit effectiveness (internal, vendor, regulatory) and closure timelines
• Change Control, Deviation, and CAPA closure timelines and effectiveness
• Quality of investigations and reduction in repeat deviations
• Timely and accurate completion of customer/regulatory questionnaires
• Vendor performance and quality metrics

Key Interfaces

Internal Interfaces

• Purchase Team
• Regulatory Team
• Projects Team
• Operations
• Corporate Quality

External Interfaces

• Vendors
• Auditors