Manager QA – EPD Quality Systems

abbott; Mumbai; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Abbott in Mumbai (BKC Building) seeks a Quality Systems professional to manage initiatives within the EPD Quality System to ensure safe, effective products and regulatory compliance.

You will support TPM and supplier quality management, lead continuous improvement of QMS processes, and coordinate with global teams. Strong communication, leadership, and data analysis are required to drive CAPAs and document management.

Qualifications

• 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.

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.

Skills

Quality Systems

Regulatory knowledge

Data analytics

Leadership

Project management

Communication

MS Office

Troubleshooting

Stakeholder collaboration

Education

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

Tools

Microsoft Excel

PowerPoint

Visio

Adobe Acrobat

Job description

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.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : BKC Building

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)