Manager QA Audit and Compliance

Main Purpose

To lead and manage the Quality Assurance Audit and Compliance function for Abbott EPD India, ensuring that all Suppliers (Mainly) third-party manufacturing sites, contract laboratories, and service providers comply with regulatory standards and internal policies. The role involves planning and executing audits, identifying compliance risks, and driving continuous improvement across the audit function.

Main Responsibilities

Prepare and schedule audits for Suppliers (Mainly) with other assigned audit such as TPMs, CTLs, warehouse / Distribution centers and service providers for new and existing sites.

Conduct “For Cause” audits to investigate quality issues and significant events.

Identify and report quality and compliance risks and gaps.

Review audit responses, track CAPAs, and ensure timely audit closures.

Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization’s quality standards.

Maintain audit records in Audit management system.

Support for preparation and publish Approved Supplier Lists (ASL).

Ensure compliance with global and local SOPs.

Support management reviews and business processes.

Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related field.

Minimum 10–15 years of experience in Quality Assurance / Quality control and diversified experience, preferably in pharmaceutical audits and compliance.

Strong knowledge of GMP, regulatory guidelines, and quality systems and able to evaluate all six system of manufacturing facility

Experience with third-party audits and supplier qualification.

Proficiency in audit documentation systems.

Excellent communication, analytical, and leadership skills.

Essential soft skills:

Strong communication and interpersonal skills.

Critical thinking and analytical ability.

Conflict resolution and stakeholder collaboration.

Ability to coach, mentor, and work cross-functionally.