Manager QA – EPD Quality Systems

Abbott Laboratories; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Abbott Laboratories in Mumbai is seeking a Quality Systems professional to manage initiatives within the EPD Quality System organization, ensuring safe, effective, and compliant products.

You will support TPM and Supplier Quality Management processes, lead continuous improvement of QMS, coordinate global initiatives with business units, and act as SME for assigned Quality Systems.

Qualifications

• 5–8 years in pharmaceutical or medical device industry.
• Knowledge of quality system regulations and compliance standards.
• Strong written and verbal communication in Business English.
• Ability to lead, influence, and collaborate with stakeholders.
• Skilled in analyzing quality data to drive strategic action plans.
• Familiar with quality improvement programs, metrics trending, and data analytics.
• Proficiency in MS Office (Excel, PowerPoint, Visio, Acrobat).
• Experience with identifying quality issues and implementing CAPAs.

Responsibilities

• Drive continuous improvement of Quality System processes and programs.
• Manage/Support the operational aspects of the Quality Management System (QMS).
• Create and maintain documentation, data, and tracking systems to support document management processes.
• Maintain understanding of regulatory expectations for EPD products and support transitions into the Business Unit.
• Lead global initiatives coordinating with Business Units to ensure implementation.
• Participate on QA cross-functional teams as necessary.
• Provide leadership as a Process Owner of assigned Quality processes per the EPD Quality System Framework.

Skills

Quality Systems

Regulatory compliance

Leadership

Project management

Data analytics

Communication (Business English)

CAPA

MS Office

Education

Bachelor’s degree in chemistry, Pharmacy, Biology, Microbiology, or related technical/scientific field

Tools

MS Office suite

Job description

Primary Job Function:

• This position is responsible for managing Quality Systems related initiatives within the EPD Quality System organization to ensure safe, effective and quality products can be supplied in accordance with regulatory and business requirements.
• This position is responsible for supporting process owners of the Quality Management System (QMS), with a focus on Third-Party Manufacturer (TPM) and Supplier Quality Management processes.

Core Job Responsibilities:

• Lead initiatives to drive the continuous improvement of Quality System processes and programs, enhancing efficiency, effectiveness, compliance, and business value.
• Manage/Suppot the operational aspects of the Quality Management System (QMS).
• Create and maintain documentation, data, and tracking systems to support efficient document management processes.

• Maintain an excellent understanding of actual and future regulatory expectations for EPD products and provide support for transition into the Business Unit as required.
• Leads global initiatives and works with the Business Units to coordinate activities and ensure implementation.
• Participate on QA cross-functional teams as necessary.
• Provide leadership as a Process Owner of assigned Quality process in line with the EPD Quality System Framework & Governance including acting as a Subject Matter Expert for assigned Quality Systems.

Supervisory/Management Responsibilities:

• Direct Reports: 0
• Indirect Reports: 0

Position Accountability/Scope:

• Reports to Head, EPD Quality Systems

Minimum Education:

• Required: Bachelor’s degree in chemistry, Pharmacy, Biology, Microbiology, or other technical/scientific area.

Minimum Experience/Training Required:

• 5-8 years’ experience in the pharmaceutical or medical device industry.
• Knowledge of relevant quality system regulations and compliance standards.
• Strong communication skills for timely, sensitive information sharing. Advanced written and verbal in Business English.
• Ability to lead, influence, and collaborate with internal and external stakeholders.
• Skilled in analyzing quality data to drive strategic action plans.
• Familiar with quality improvement programs, metrics trending, and data analytics.
• Proficiency in MS Office suite of tools such as Microsoft Excel, PowerPoint, Visio, Adobe Acrobat.
• Strong Leadership, project management and troubleshooting skills to drive resolution of complex issues.
• Experience with identifying Quality issues and implementing Corrective and Preventive actions.