Sr. Manager, Quality Laboratories
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.
Manages the staff and oversees the processes of the chemical analysis and release of raw materials, in-process and final products to assure that products meet regulatory and corporate quality standards. This position requires thorough scientific knowledge and technical expertise in the field of chemistry, technical writing, investigation and problem solving and regulatory requirements.
This position is responsible for the following:
- Provides day to day supervision of employees performing moderate and high complex testing.
- Monitors test analysis to ensure that acceptable levels of analytical performance are maintained.
- Develops and manages department budget, hiring and development of employees, and assuring the performance of the department both financially and qualitatively.
- Provides technical support and direction to other functional areas of the corporation.
- Supports corporate projects and global quality initiatives.
- Serves as the subject matter expert for audit inquires and responses.
- Other duties and special projects as assigned.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
BS Degree in Chemistry or related major
Previous Supervisory or managerial experience
Extensive experience with Computerized data acquisitions, HPLC, "Wet Chemistry" procedures LIMs (preferred). MS Office (Word, Excel, PowerPoint). QMS / Trackwise (preferred). SAP (preferred)
Five (5) years of industrial Chemical Laboratory experience and working knowledge of regulatory requirements.
Knowledgeable in the manufacture of pharmaceuticals with experience in process and method validation
Essential Knowledge, Skills & Abilities:
- Experience using and maintaining analytical equipment
- Excellent analytical and problem-solving skills
- Ability to understand and make use of technical writings
- Excellent written documentation skills
- Proven ability to work effectively with others
- Good oral and written communication skills
Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
Job Level Code
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.