Associate Principal Quality Partner

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Job Description

The Associate Principal Quality Partner provides leadership and direction for Quality Assurance activities within Operations and serves as a senior quality resource for assigned functional areas. This role is accountable for driving effective implementation of quality systems, compliance oversight, and sound quality decision-making across the area of responsibility. The position focuses on product and process compliance, issue resolution, quality governance, and strategic quality improvement.

This role partners closely with Operations, Manufacturing, Development, Regulatory, and other stakeholders to ensure compliance with Abb Vie Quality Systems, cGMP requirements, and applicable regulatory expectations. The role is expected to maintain strong quality performance while driving efficiency, continuous improvement, and effective escalation of quality risks, trends, and systemic issues. The Associate Principal Quality Partner is also expected to proxy for the team manager as needed and provide leadership to cross-functional and team-level strategic initiatives.

Responsibilities

* Serve as a Associate Principal Quality Partner for one or more functional areas, including Manufacturing, Supply Chain, Engineering, and Quality Control, providing strategic quality oversight for critical phases of Operations and Manufacturing to ensure sustained compliance with applicable GxP requirements.

* Act as a proxy for the team manager as needed, representing QA in operational discussions, prioritization decisions, escalation forums, and cross-functional meetings.

* Complete, review, and approve impact assessments for nonconformances, ensuring robust risk evaluation, sound decision-making, and complete supporting documentation.

* Act as a senior QA approver and governance resource for SOPs, compliance records, NCRs, CAPA plans, effectiveness checks, and other quality system deliverables.

* Provide quality leadership and direction for site projects, compliance initiatives, and cross-functional programs, ensuring quality requirements are embedded early and consistently throughout execution.

* Partner with Production, Supply Chain, Engineering, Operations, and Quality Control leadership to identify systemic risks, influence corrective actions, and prevent recurrence of quality issues.

* Exercise oversight of record completion timeliness and quality, ensuring documentation is complete, accurate, compliant, and aligned with procedural expectations.

* Ensure projects and operational changes are executed in accordance with current Good Manufacturing Practices (cGMP), ISO standards, internal quality policies, and applicable regulatory requirements.

* Lead and/or oversee corrective and preventive action strategies, ensuring effective implementation, sustainability, and measurable improvement in quality performance.

* Provide senior-level support for quality incident investigations, including root cause analysis, risk assessment, resolution planning, and escalation as appropriate.

* Represent Quality Assurance in internal and external audits, inspections, and regulatory interactions as needed, supporting audit readiness, issue resolution, and response coordination.

Qualifications

* Bachelor's Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering

* 8+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry

* Must be familiar with use of electronic document management and laboratory information management.

* Must also be familiar with Abb Vie Quality Systems as well as cGMP and other regulatory requirements.

* Strong communication Skills, both oral and written

Preferred

* 5 years of quality experience on shop floor with focus on the following areas:
1.Deep GxP / cGMP quality assurance experience, 2.Quality issue resolution, risk assessment, and governance, 3.Cross-functional influence and partnership, 4.QA shop floor / manufacturing and QC lab presence, 5.Senior-level judgment and leadership is highly desired

* Experience supporting quality issue resolution, compliance oversight, and cross-functional quality leadership is desired

* Familiarity with electronic document management systems and quality/business systems is desired.

* Demonstrated ability to lead through influence and partner effectively across functions is desired.

* Strong analytical, organizational, and problem-solving skills is desired.

Additional Information

Applicable only to…