Senior Manager, Combination Products & Medical Devices
AbbVie
August 19, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Operations
Purpose:
- Primary responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.
Responsibilities:
- Manage and oversee interrelated design control activities with R&D, Science and Technology, Operations QA, Supply Chain, RA, and other R&D QA functions; influence decisions of R&D/Operations Directors and external customers.
- Lead complex global cross-functional quality system process improvement teams.
- Assure integration and support of device, drug, and as appropriate biologics regulations; ensure compliance with company policies and procedures.
- Perform design control activities: mentor/lead product teams, identify/address product issues, ensure robust product vs. customer requirements, and manage interfaces to drug development where appropriate.
- Ensure design control documentation (traceability/linkages) and design change control requirements are met; assess and justify safety/efficacy impacts of changes and cumulative changes.
- Collaborate on risk management to identify and mitigate product risks.
- Manage 3rd party supplier activities (review/approval of design control activities, supplier change assessment, balance internal oversight vs supplier controls, quality agreements input, supplier site visits); support supplier audits.
- Identify process gaps and lead solution development/implementation.
- Guide project development to proactively avoid or address quality-related issues.
- Provide QA consultation/training to internal and cross-functional groups.
- Support regulatory inspections and internal audits; represent GMP QA as SME.
Qualifications:
- Bachelor’s degree (preferably sciences/engineering/technical/scientific).
- 6+ years industry experience in Quality Assurance, Development, or healthcare; medical device regulation experience required; Combination Product and 3rd party supplier management preferred (advanced degree may substitute).
- Broad understanding of regulations/standards for combination products and medical devices; leadership and ability to justify Quality positions.
- Technical understanding of product development and/or practical design control experience.
- Proficient in risk management methodologies.
- Leadership competencies (decision-making, relationship-building, influencing, teamwork) and strong analytical/judgment skills.
- Initiative to identify/implement new approaches; challenge scientific arguments.
- Ability to work independently and in global teams with all levels of personnel.
- Primary responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.
Responsibilities:
- Manage and oversee interrelated design control activities with R&D, Science and Technology, Operations QA, Supply Chain, RA, and other R&D QA functions; influence decisions of R&D/Operations Directors and external customers.
- Lead complex global cross-functional quality system process improvement teams.
- Assure integration and support of device, drug, and as appropriate biologics regulations; ensure compliance with company policies and procedures.
- Perform design control activities: mentor/lead product teams, identify/address product issues, ensure robust product vs. customer requirements, and manage interfaces to drug development where appropriate.
- Ensure design control documentation (traceability/linkages) and design change control requirements are met; assess and justify safety/efficacy impacts of changes and cumulative changes.
- Collaborate on risk management to identify and mitigate product risks.
- Manage 3rd party supplier activities (review/approval of design control activities, supplier change assessment, balance internal oversight vs supplier controls, quality agreements input, supplier site visits); support supplier audits.
- Identify process gaps and lead solution development/implementation.
- Guide project development to proactively avoid or address quality-related issues.
- Provide QA consultation/training to internal and cross-functional groups.
- Support regulatory inspections and internal audits; represent GMP QA as SME.
Qualifications:
- Bachelor’s degree (preferably sciences/engineering/technical/scientific).
- 6+ years industry experience in Quality Assurance, Development, or healthcare; medical device regulation experience required; Combination Product and 3rd party supplier management preferred (advanced degree may substitute).
- Broad understanding of regulations/standards for combination products and medical devices; leadership and ability to justify Quality positions.
- Technical understanding of product development and/or practical design control experience.
- Proficient in risk management methodologies.
- Leadership competencies (decision-making, relationship-building, influencing, teamwork) and strong analytical/judgment skills.
- Initiative to identify/implement new approaches; challenge scientific arguments.
- Ability to work independently and in global teams with all levels of personnel.