Describe the primary goals, objectives or functions or outputs of this position.
This individual will be responsible for supporting activities for Combination Products, Pharmaceutical products and medical devices, support the strategic direction to ensure business objectives are met to support and sustain the quality system in Combination Products, Pharmaceutical products, and medical devices and complete quality assurance activities to develop, implement and sustain required regulations to comply to global regulations.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Assure proper integration and support of device, drug and Biologics regulations.
Areas of direct responsibility include development and maintenance of QA procedures for risk management that support AbbVie’s business objectives, functional area strategies, and the overall quality system.
Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.Oversee the implementation and management of training programs for pharmaceutical products, medical devices and combination products including leadership, business curriculum and training plans.
Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing pharmaceutical products, medical devices and combination products.
Represent AbbVie on External Industry groups where appropriate. Represent AbbVie as the Quality Assurance subject matter expert during internal and external regulatory inspections related to risk management. Work with external and internal partners to establish best in class practices for risk management, validation and other related quality systems for pharmaceutical products, medical devices and combination products.
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.
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.