Manager, QA

AbbVie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

The Quality Manager provides leadership and direction to the quality function they are responsible for within Operations. Role is responsible for the effective implementation of AbbVie Quality System for which they are responsible for. This could include be two or more of the following areas: Exemptions, CAPA System , IT systems QA support, Complaints, APR/PQR’s, Risk management , Metrics, management Reviews, Change Management, Incoming Quality , QA Floor support, Batch Record Release, Training, Material control , Internal and External Inspections.  The incumbent act as inspector administrator during external inspections.

• Lead a team of Quality professionals who execute the quality activities. Responsible for all aspects of personnel management: hiring, setting performance expectations, performance, and development
• Responsible for the effective implementation  and compliance with AbbVie requirements for two or more of the following areas: Exemptions, CAPA System , IT systems QA support, Complaints, APR/PQR’s, Risk management , Metrics, management Reviews, Change Management, Incoming Quality , QA Floor support, Batch Record Release, Training, Material control , QA contract manufacturing , Internal and External Inspections.
• Responsible for first level decisions in their areas. Decisions that may impact product quality and company compliance status.
• Reviews and approved Quality system documents and records.
• Manage internal and external audits, acting as inspector administrator, providing responses, and developing improvement plans.
• Manage Quality aspects with clients (Third Party contracts) : quality agreements , events discussion and change management process.
• Provide regulatory and compliance guidance to other operations functions at the site.Drive improvement at manufacturing areas.
• Participate in the development of AbbVie process and procedures as member of the AbbVie Center of Excellence.
• Lead quality plan projects: Analyze Quality data, identify areas of improvement, define plans, and assure execution of plans.
• Represent Quality function in Management reviews, operations performance indicators review meeting and global meetings.

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Bachelor’s degree in science or Engineering. Master’s degree is highly desirable.
Eight plus (8+) year of experiences in pharmaceutical, biologics, device, or chemical industry.
Experience in the manufacturing of sterile, aseptic, and biological products.
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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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