Sr Manager- Quality Control Analytical
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.
The Sr. Manager, Quality Control Analytical provides leadership and direction to the Quality Function they are responsible for within Operations. This Sr. Manager role is responsible for maintaining a culture of safety, inclusiveness, and compliance within the QC Laboratory through the effective implementation of AbbVie Policies and Quality Systems. This position will oversee the quality control testing of incoming raw materials, in-process, release and stability samples for biologics drug intermediates, drug substances and drug products. This position serves a critical function in maintaining timely support of manufacturing and ensuring batch release and stability testing timelines are achieved. In addition to the oversight of laboratory testing, the Sr. Manager, Quality Control Analytical will be responsible for the management of laboratory equipment commissioning/qualification, preventive maintenance, and calibration. The leader within this role will drive communication of team performance, through management of laboratory KPI’s, internally within Quality Control as well as cross functionally within plant operations leadership.
- Responsible for various aspects quality control related to products produced at the plant. This position is responsible for the Quality Control Analytical oversight for a large plant with high volume, high level of product complexity including multiple products at the site and may have the complexity of multiple types of productions (API, Fin Goods, Biologics)
- Ensures that product within the plant is consistently manufactured in conformance with corporate Quality requirements and all applicable regulatory requirements.
- Manages a team of quality professionals. Directly responsible for the effective organization, administration, training and supervision of their functional area. This is to include the maintenance of culture driving a safe and inclusive workplace.
- Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
- Incumbent is responsible for quality decisions related to laboratory controls to ensure that the laboratory maintains compliance with cGMP, FDA, EU, DEA and other regulatory requirements.
- Minimum Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; Master’s Degree or PhD preferred.
- Certified Quality Engineer or formal training in quality engineering or statistics is preferred
- 8+ years of combined experience in Manufacturing, QA, QC in pharmaceutical, biologics, device or chemical industry
- 4+ years of supervisory/technical leadership experience.
- Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
- Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
- Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
- Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Digital Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.
- Strong communication Skills, both oral and written;
Key Stake Holders:• Development, Manufacturing, Quality and Regulatory
Significant Work Activities
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.