Manager, Design Quality Lifecycle Management

Purpose
Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market. Responsible for assuring compliance to local divisional and corporate policies and external agency regulations worldwide. Products include medical devices and combination products such as infusion pumps enteral and sub-cutaneous tubing Pre-filled Syringes Autoinjectors Eyecare Products Aesthetics Devices etc. 

Responsibilities

• Primary driver for the quality and compliance aspects of Design transfer and on-market change management.
• Serve as the primary quality lead for design transfer activities to enable product launch including transfers both within and outside of AbbVie.
• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
• Own change plans to manage on-market design changes collaborate with cross-functional team for impact assessments define and execute action plans and monitor to ensure timely closure.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Assist 3rd party suppliers during change management process including change management strategies.
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation.
• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
• Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities.  Implements agreed strategy.
• Make recommendations for key decisions on product quality compliance and regulatory conformance issues.
• Establish and maintain relationships and open communication with suppliers contract manufacturers AbbVie plants affiliates and other functional groups to maintain roles and responsibilities identify potential projects and issues obtain an in-depth understanding of the quality compliance and resource needs at each site and provide guidance on quality concerns.
• Initiate assignments independently.  Actively lead and participate on development and process improvement teams.  Anticipate/resolve quality issues and take preventative actions.
• Actively monitor effectiveness of processes and quality of project work propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents.
• Conduct lead or participate in investigations and review boards for Change Plans CAPAs NCRs Observations etc.

Qualifications :

• Bachelors degree in science engineering or other technical areas; or equivalent job experience required. Advanced degree preferred; ASQ certification preferred (CQA CQE SSBB etc.)
• 8 years of relevant experience in the medical device industry;  at least 5 years in Quality Assurance experience required.
• Working knowledge of ISO 13485 ISOCFR 4 21 CFR 820 EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).
• Working knowledge of international standards and regulations applicable to medical devices and combination products.
• Experience with medical devices and/or combination products such as infusion pumps PFS Autoinjector or Eyecare Products preferred.
• Ability to apply practical and technical problem solving to quality system and product improvements.
• Excellent interpersonal skills including ability to work effectively cross-culturally and cross-functionally.
• Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.
• Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues areas of expertise and utilizes them effectively to achieve team objectives.
• Champions high quality deliverables innovation and appropriate risk-based decision making; Ability to understand the sensitivities within the AbbVies environment.
• Excellent project management and interpersonal skills.
• Adaptable to changes in work environment.
• Ability to work in a fast-paced environment.

Key Stakeholders 
External Manufacturing Business Relationships Operations Third Party Manufacturers Business Alliance Commercial Global Supply Chain Domestic and International AbbVie Plants and Affiliates Regulatory Affairs Research and Development.

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. Salary: $106500 - $202500

• 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 short-term incentive programs. 

• This job is eligible to participate in our long-term 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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