Manager, Quality Assurance -Pharmaceutical:
AbbVie

899164632
AbbVie
Irvine California
Pharmaceutical
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Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. All while wearing jeans to work!

Manager, Quality Assurance - Irvine, CA

WHAT YOUR NEW MANAGER WANTS YOU TO KNOW:

" I'm looking for a highly motivated and focused individual that can lead in a fast-paced Quality Assurance environment. Our products change people's lives every day and you should want to do the same. Our Manager, Quality Assurance will interact with clients across all aspects of the business"

*YOU ARE more than just a title, YOU ARE...

Managing and administrating the BLI plant quality systems including CAPA, deviation, change control, OOS, complaint, and work order systems. Supporting any plant or corporate driven initiatives to enhance these systems. You are responsible for assessing and approving quality system documentation. This includes implementing and coordinating all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation.

YOU WILL:

Be the BLI Quality Expert. You will present and defend quality management records and actions during FDA and Ministry of Health inspections and internal audits. You will be responsible for quality records and systems within the Quality Management System (Trackwise) and you will be able to make final quality decisions on routine records while knowing when records require escalation to the Site Quality Head. You will manage the quality review function and ensure that all quality documents, including batch records, are reviewed in a timely manner, the review function will also be responsible for generation of APR's, stability reports, and other annual Quality Reports.

Be the Leader of QA Projects. Identify and update appropriate procedures to assist in the management of QA system to ensure closure and approval. Integration, preparation and distribution and review of product documentation, master batch records, media holds etc. to support operations and quality control departments consistent with corporate objective, GMPs, and regulatory requirements

Be the LMS and Documentation Leader. You will manage and administrate the plant GMP and Learning Management System (LMS) training program. You will support any plant or corporate driven initiatives to enhance the training system. You will manage the Document Control Center and ensure that all necessary controls are in place for issuance, approval, and review of GMP documents. The position will ensure all relevant CORAL functionality is used and has been implemented as per corporate project plan.

Qualifications

YOU BRING:
  • BS degree in Chemistry, Biochemistry or related discipline or a combination of education and experience.
  • 5-8 years of related QA systems experience is required. Experience in Biotech or a Biopharmaceutical environment is highly desired.
  • A thorough understanding of cGMP regulations and experiences in regulatory inspection is required.


Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.
Basic Qualifications
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