Associate Principal Quality Partner

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 AbbVie 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 :

• Bachelors 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 AbbVie 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 applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors  including  geographic location and we may ultimately  pay more or less than the posted range. This range may be  modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to  participate in our short-term incentive programs. 

Note: No amount of pay is  considered to be wages or compensation until such amount isearned  vested  and determinable. The amount and availability of  any bonus commission incentive benefits or any other form of compensation and benefits that areallocable to a   particular employee  remains in the Companys sole and absolute discretion unless and until paid and may be  modified at the Companys sole and absolutediscretion  consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time