Abbott - Manager - Quality Assurance Audit & Compliance

Main Purpose:

Main Responsibilities:

Audit Planning & Execution:

- 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 organizations quality standards.

Documentation & Reporting:

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

- Ensure compliance with global and local SOPs.

- Support management reviews and business processes.

Qualifications & Experience:

- 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:

- Critical thinking and analytical ability.

- Conflict resolution and stakeholder collaboration.

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