Overview
Quality Assurance Manager role at AbbVie. This role is responsible for ensuring that all products manufactured at AbbVie meet GMP, end-user, Regulatory Authority, and AbbVie standards. The QA Manager will oversee team performance, compliance activities, audits/inspections, and serve as a critical partner to operational functions to maintain and improve quality across the site.
Responsibilities
* Ensure products manufactured at AbbVie meet requirements of end users, Regulatory Authorities, and AbbVie.
* Lead and manage the Quality Assurance team, providing guidance and support on quality and compliance matters.
* Act as a site contact for regulatory and customer audits/inspections (FDA, HPRA, etc.) and prepare site teams for successful outcomes.
* Manage CAPA (Corrective and Preventive Action) implementation, and follow-up activities.
* Collaborate cross-functionally to resolve quality issues, improve processes, and ensure continuous compliance with cGMP and other relevant regulations.
* Promote department goals by attracting, developing, and retaining capable QA staff.
* Contribute to talent management and professional development of QA personnel.
* Develop, review, and approve QA documentation as related to general QA activities.
* Provide oversight of batch record review, deviation investigations, change controls, and product release decisions.
* Support quality meetings and key quality metrics and trends.
* Communicate effectively with internal and external stakeholders, including the AbbVie Quality and Compliance Group and regulatory bodies.
* Serve as a designee for the Biologics Quality Director as required.
Qualifications
* Bachelor's degree in science, Quality, Engineering, or related field (Master’s preferred)
* Minimum of 8 years’ experience in the healthcare, pharmaceutical, or biopharmaceutical industry
* At least 3 years’ supervisory/people management experience
* Demonstrated experience with audits and/or inspections (FDA, HPRA, etc.)
* High level of expertise in day-to-day quality and compliance decision-making
* In-depth knowledge of GMP requirements and regulatory frameworks
* Strong attention to detail and commitment to compliance and quality standards
* Ability to facilitate quality decision-making while maintaining a strong patient focus and upholding AbbVie’s reputation
Additional Information
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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