Manager Quality Risk Management

Purpose

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.

Responsibilities

• 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 AbbVies 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 crossfunctional 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 :

Qualifications

• 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 crossfunctional teams with resultsorientation.
• 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.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

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