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 prospect in ACG Capsules of a Manager – Vendor Management & Compliance, Central Quality Assurance, Quality and Regulatory Affairs.

1. 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.

1. 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.

1. 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

1. Key Interfaces

Internal Interfaces

External Interfaces

- Purchase Team
- Regulatory Team
- Projects Team
- Operations
- Corporate Quality

- Vendors
- Auditors

📌 Manager - Central Quality Assurance (Vendor Management & Compliance), ACG Capsules (India)
🏢 ACG
📍 India