AbbVie

Senior Manager, R&D Quality Assurance

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Jan 08, 2021
Ref
2009254
Required Education
Bachelors Degree
Position Type
Full time
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 .

The Senior Manager, R&D Quality Assurance provides leadership and direction to the Quality Function they are responsible for within RDQA. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Quality Engineering, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality leads a team of quality professionals who are responsible for compliance and quality oversight for the plant and/or strategic initiatives. Expectations that the professional will maintain high quality levels on all products while achieving high efficiency.

Responsibilities:
  • Responsible for various aspects of quality assurance related to products produced at the plant.
  • Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the site.
  • 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.
  • Provides regulatory and technical guidance to the plant.
  • Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
  • Incumbent is responsible for quality decisions related to all aspects of the plant operation and to ensure that the area of their responsibility meets all cGMP, FDA, EU, DEA and other regulatory requirements.

Qualifications

Qualifications:
  • 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 experience in function or related field.
  • 5+ years in a leadership role with strong management skills.
  • 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, Quality Control, Information 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

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.