Manager QA – EPD Quality Systems
Location: Mumbai, Maharashtra, India
Category: Quality Assurance / Quality Systems
Industry: Pharmaceutical / Medical Devices
Experience Required: 5–8 years in Pharmaceutical or Medical Device Quality Systems
Job Overview
We are seeking a highly skilled Manager QA – EPD Quality Systems to lead and manage strategic quality initiatives within the Established Pharmaceuticals Division (EPD). The role ensures that robust Quality Systems are maintained to support the supply of safe, effective, and compliant products in accordance with regulatory and business requirements.
This position plays a key role in managing the Quality Questionnaire Program for suppliers and Third-Party Manufacturers (TPMs), driving compliance excellence, and strengthening global quality governance.
Key Responsibilities
Quality Systems Management
Lead and manage Quality Systems initiatives aligned with the EPD Quality System Framework and governance model.
Serve as Process Owner for assigned quality processes and ensure continuous improvement.
Act as Subject Matter Expert (SME) for designated Quality Systems.
Lead global quality initiatives in collaboration with Business Units to ensure effective implementation.
Supplier & Third-Party Manufacturer Oversight
Manage the Quality Questionnaire program for EPD suppliers and TPMs, including scheduling, execution, and compliance tracking.
Review completed questionnaires for accuracy, completeness, and regulatory alignment.
Collaborate with Supplier and TPM QA teams to resolve gaps and ensure timely completion.
Regulatory Compliance & Risk Management
Maintain strong knowledge of current and emerging regulatory expectations for EPD products.
Support business transitions and regulatory alignment activities.
Identify quality risks and drive Corrective and Preventive Actions (CAPA).
Analyze quality data and trends to develop strategic improvement plans.
Documentation & Data Governance
Create and maintain documentation, tracking systems, and data management processes to ensure efficient document control.
Ensure compliance with global quality standards and regulatory documentation requirements.
Cross-Functional Collaboration
Participate in QA cross-functional teams to support compliance and product lifecycle initiatives.
Communicate critical quality information effectively to internal and external stakeholders.
Required Qualifications
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, or a related scientific discipline.
5–8 years of experience in Quality Assurance or Quality Systems within the pharmaceutical or medical device industry.
Strong understanding of global quality regulations and compliance standards.
Experience in supplier quality management and third-party manufacturer oversight.
Proven expertise in CAPA implementation, quality metrics trending, and data analytics.
Technical & Professional Skills
Strong leadership, project management, and problem-solving abilities.
Ability to influence and collaborate with global stakeholders.
Advanced written and verbal communication skills in Business English.
Proficiency in MS Office tools including Excel, PowerPoint, Visio, and Adobe Acrobat.
Experience managing complex quality issues and driving process improvements.
Reporting Structure
Reports to: Senior Manager QA – EPD Quality Systems & Strategy
Direct Reports: None
Apply now through ThePharmaDaily.com to advance your career in Pharmaceutical Quality Systems and Global QA Leadership.
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