Quality Risk Manager Program Manager
- Employer
- AbbVie
- Location
- Lake County, Illinois
- Start date
- Jun 3, 2023
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest, Best Places to Work
Job Details
Design, develop and deliver a comprehensive risk management program for pharmaceutical, combination and medical device products across the company. Chair and charter governance programs in relation to managing the quality systems related to risk management. Implementing and maintaining the effectiveness of the quality system including compliance with Corporate, Division, and Site policies.
The individual may interact with AbbVie Executives as well as with R&D, manufacturing science and technology, supply chain, program management and Regulatory Affairs management; therefore requires high levels of competence, confidence, and credibility. Managing or participating on cross-functional teams to ensure that the needed functional expertise is involved so that all products are compliant. Works with management and the department to achieve related goals and strategic initiatives. Manages the interrelated function activities related to medical device and pharmaceutical products including design control. Typically includes Manufacturing, S&T, Program Mgmnt., Regulatory, R&D, Supply Chain, Commercial, Pharmacovigilance, 3rd Parties Ensuring QA/regulatory compliance for all assigned product(s). This includes management of QA project/initiatives to define AbbVie processes and develop AbbVie quality systems to support device and combination product quality compliance. Direct product QA responsibility for assigned quality systems, devices and combination product(s). This includes partnering with R&D, Manufacturing and Third Party Vendors/Manufacturers to ensure that all assigned quality systems and products are in compliance with all AbbVie and Regulatory Agency standards.
Qualifications List required and preferred qualifications (up to 10). Include education, skills and experience. Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area Minimum of 6 years experience with quality assurance and/or quality system oversight. Risk Management and Device regulation experience preferred. Leadership of other technical professionals and experience in leading cross-functional teams with results-orientation.
Skilled in the strategy development, initiation, selection, coordination and management of projects and have the ability to solve unique problems. Knowledge of regulations and standards affecting devices, biologics and pharma products. Knowledge of ICH standards, ISO standards, US Code of Federal regulations, and the EU regulations. Understands impact of specific area system changes to other quality systems as well as changes within division
requirements and impact to specific area of control and able to adjust accordingly.
Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills a plus. Previous experience with regulatory agency interface preferred.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
Company
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, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
- Website
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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