Manager Medical Device External Quality

Purpose:

The Manager Medical Device External Quality is part of AbbVies External and Product Quality Assurance group and reports to the Senior Manager Medical Device External Quality. The role will be based out of Lake County IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties. In this capacity the Manager Medical Device External Quality champions best practices related to sustaining product quality equipment qualification and manufacturing process validations.

As such the Manager Medical Device External Quality works closely with AbbVies Contract Manufacturing Organizations (CMOs) relevant thirdparty suppliers (e.g. custom components) and internal stakeholders to ensure compliance with defined specifications and regulatory requirements. The position also supports Quality Management System activities related to the CMOs including but not limited to CAPAs/NCRs Change Control Complaints Product Release Supplier Quality Agreements etc. Additionally the Manager Medical Device External Quality may support New Product Introduction activities with particular emphasis on transfertomanufacturing. The Manager Medical Device External Quality provides strong technical leadership in the TPQ Quality function amongst peers ensuring that functional activities are compliant and aligned with overall company goals and strategies.

Responsibilities:

•  Manages CMOs and/or thirdparty suppliers to assure timely and compliant release of commercial products and/or components in accordance with defined specifications and processes.
•  Oversee CMOs and/or thirdparty suppliers to ensure that nonconformances CAPAs Reworks and deviations are accurately documented reviewed and approved as well as resolving compliance issues related to commercial product and/or custom components
•  Supports New Product Introduction (NPI) activities
• Develops and maintains supplier Quality Technical Agreement. Review and approve changes to supplier processes which impact device and/or component manufacture.
• Review and approve technical protocols reports and specifications as appropriate.
•  Supports Quality Systems group during Regulatory inspections (i.e. serve as product SME)
•  Participates in the development of global Product Quality Assurance strategy to support medical devices and/or combination products produced at third party manufacturing (TPM) facilities.
• Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers if required.
•  Interfaces with Global Quality Assurance audit team to develop audit plans due diligence plans and inspection readiness plans review audit observations and responses and maintain corrective action timetable. Support Supplier Audit function during CMO site audits.
•  Leads management reviews with assigned Third Party Manufacturers that identify and address quality operational and organizational issues. Champions development and maintenance of KPIs and trend analysis at supplier site as applicable

Qualifications :

Qualifications

Bachelors Degree in relevant Life Science or other technical discipline or equivalent job experience required.

7 years of total combined experience. At least 5 years in Quality Assurance Operations

Management; 3 years in Operations Research and Development or Consulting.

Knowledge and a comprehensive understanding of some biological and/or pharmaceutical

technologies (sterile biological liquid ointments devices solid tablets and caplets

suspensions granulations soft elastic capsules gel caps extended release products coating

solutions and/or active pharmaceutical ingredients).

Possesses knowledge and a skill set to operate within an environment that requires a high

degree of urgency strong analytical and problem solving skills positive interpersonal skills

ability to manage multiple complex tasks simultaneously and capable of performing as

leaders members and individuals.

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.

• 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 serving our community and embracing diversity and inclusion.  It is AbbVies 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 protected veteran or any other legally protected group status.

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Work :

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