Manager, Medical Device External Quality

About the role

The Manager, Medical Device External Quality is part of AbbVie's External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role is based out of Lake County, IL site.

Responsibilities

• Oversee external product quality assurance (EPQA) for commercial medical devices manufactured by third parties.
• Sustain product quality, equipment qualification, and manufacturing process validations.
• Work closely with AbbVie's Contract Manufacturing Organizations (CMOs), relevant third-party suppliers, and internal stakeholders to ensure compliance with defined specifications and regulatory requirements.
• Support Quality Management System activities related to CMOs, including CAPAs/NCRs, Change Control, Complaints, Product Release, Supplier Quality Technical Agreements, etc.
• Support New Product Introduction activities, with particular emphasis on transfer-to-manufacturing.
• Provide strong technical leadership in the TPQ Quality function amongst peers.
• Manage CMOs and/or third-party suppliers to assure timely and compliant release of commercial products and/or components in accordance with defined specifications and processes.
• Oversee CMOs and/or third-party suppliers to ensure that non-conformances, CAPAs, Reworks, and deviations are accurately documented, reviewed, and approved as well as resolving compliance issues related to commercial product and/or custom components.
• Support Late-Stage Development and/or New Product Introduction (NPI) activities.
• Develop and maintain supplier Quality Technical Agreements. Review and approve changes to supplier processes which impact device and/or component manufacture.
• Review and approve technical protocols, reports, and specifications, as appropriate.
• Support Quality Systems group during Regulatory inspections (i.e., serve as product SME).
• Participate in the development of global Product Quality Assurance strategy to support medical devices and/or combination products produced at third party manufacturing (TPM) facilities.
• Perform final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers if required.
• Interface 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.
• Lead quality reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.
• Champion development and maintenance of KPIs and trend analysis at supplier site, as applicable.

Qualifications

• Bachelor's 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.

Skills

• Strong analytical and problem-solving skills.
• Positive interpersonal skills.
• Ability to manage multiple complex tasks simultaneously.
• Technical leadership in Quality Assurance Operations Management.

Benefits

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 long-term incentive programs.

Pay

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

Schedule

Not specified.