Sr Mgr, Quality Laboratories

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 www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

Mgr, Quality Laboratories

What Your New Manager Wants You To Know

I am looking for an experienced Sr. Manager, QC Labs will act as subject matter expert (SME) on microbiology, sterilization, and production clean room controls including aseptic processing and environmental monitoring.

Sincerely,

Sr. Mgr, Quality Laboratories

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

A strategic thinker : Align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : Collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

• M anagement of Quality Control Laboratory personnel and activities, including QC Testing, Finished Product Testing, Microbiology Testing and the LIR/NCR/CAPA/Change Control processes as they relate to the laboratory.
• Responsible for bringing innovative solutions to complex problems, especially in the areas of improved efficiencies and automation.
• Ensure there is adequate, trained staff to accomplish Quality objectives, and ensure the collection, organization, analysing and reporting on data regarding non conformances (OOS), and other quality issues, as determined by the Sr. Mgr. Quality Control.
• Establish in-house capability of microbiological testing and microbial identification. Provide hands on guidance and training to junior level associates on laboratory testing and assure overall compliance to cGMPs and GDP.
• Design and lead sterilization and microbiological needs of project teams based on regulation and guidelines, which includes autoclave loading pattern, terminal (ebeam) sterilization of product, in-process bioburden reduction and testing.
• Assist with the development and implementation of policies and procedures as they pertain to all QC and Microbiology laboratories supporting the overall Quality program.

Qualifications

You Bring

• 5-10 yrs. with Ph.D.
• >10 yrs. with a Bachelor or Master's Degree
• Daily management of 4 direct and approximately 36 indirect laboratory staff
• Extensive knowledge/experience of sterilization process, aseptic processing and clean room regulations, industry practices, quarterly dose audit and related ISO standards.
• Experience with Microsoft Office Applications including Word, Excel, PowerPoint, and Outlook. Experience and knowledge in Data Integrity and governing regulations.
• Ability to serve as a senior technical advisor. Ability to communicate at all levels and deliver highly technical information in clear and easy-to-understand terms.
• Demonstrated organizational development skills. Able to identify, challenge and mentor department associates providing feedback, guidance and direction supporting individual development.
• Organize and prioritize tasks and effectively communicate priorities to direct reports, peers and management.
• In-depth knowledge in FDA, ISO, AATB, and USP regulations/guidelines.
• Demonstrated experience working with internal and external customers. i.e. vendors, collaborating investigators, contract test labs. Comprehensive understanding of microbiology, aseptic processing and sterilization.
• Willingness to work with potentially bio-hazardous materials including human and animal tissues and a variety of media.
• Reviews sterilization microbiological practices against current industry regulations.
• Experience developing sterilization methods; steam sterilization, radiation, aseptic processing.
• Experience with regulatory guidelines for sterilization, microbiological, analytical and histological practices relating to clean room manufacturing, aseptic processing, and sterilization of human tissue, medical devices or pharmaceuticals.
• Demonstrated mathematical, statistical, communication, technical writing, presentation, critical thinking and problem-solving skills.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.