Senior Manager, Combination Products & Medical Devices

About the role

The Senior Manager, Combination Products & Medical Devices is responsible for representing Quality Assurance (QA) on cross-functional teams involved in the development of combination products and medical devices. They ensure these products comply with worldwide regulations and manage interrelated function activities related to design control.

Responsibilities

• Manage and oversee the interrelated function activities related to design control with R&D functions, Science and Technology, Operations QA, Supply Chain, RA, and other R&D QA functions. Interact with and influence decisions of various R&D and Operations Directors and external customers.
• Lead complex global cross-functional quality system process improvement teams.
• Assure proper integration and support of device regulations, drug regulations, and appropriate biologics regulations. Ensure compliance with company policies and procedures.
• Perform design control activities: mentor and lead product team members through the design process, providing guidance. Work closely with research organizations to identify and address potential product issues during the design phase. Ensure robust product vs. customer requirements and interfaces with drug development as appropriate.
• Ensure design control documentation (traceability/linkages) and design change control requirements are met. Assess the impact of changes on safety, efficacy of the combination product/device. Analyze and justify the impact of cumulative changes.
• Risk Management: Global collaboration with R&D and Commercial Operations functions to identify and mitigate product risks to develop robust combination products and medical devices.
• Perform third-party supplier management activities such as reviewing and approving third-party design control activities, assessing supplier changes, establishing appropriate balance between internal oversight actions and supplier controls, providing input to quality agreements, performing relationship development, suppliersite visits, etc. Support supplier audits as required. Partner with Third Party Vendors/Manufacturers/Laboratories to ensure combination products/devices are compliant with internal and Regulatory Agency standards.
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation.
• Guide project development as a team member in global and local product development teams for combination products to proactively avoid or appropriately address quality-related issues.
• Provide consultation and training on specific QA expertise to internal and cross-functional groups.
• Support the preparation of regulatory inspections and internal audits and represent GMP QA in inspections and audits as SME.

Qualifications

• Bachelor's degree is required; preferably in sciences, engineering, or other technical/scientific area.
• Minimum 6+ years of industry experience in Quality Assurance, Development, or healthcare-related field. Medical device regulation experience required. Combination product and third-party supplier management experience preferred. Less experience considered with advanced degree.
• Broad understanding of regulations and standards affecting combination products and medical devices required. Must have leadership skills and be capable of taking a position on quality issues and standards and clearly and logically justify such positions.
• Sound technical understanding of product development (e.g., approaches for defining requirements and specification setting for verification and validation) and/or practical experience in design control.
• Well-versed in risk management methodologies and their application.
• Key leadership competencies and making difficult decisions, relationship-building, fostering teamwork. Knowledge of the business and sound judgment.
• Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions.
• Work independently and in a global team environment, and with all levels of personnel within the organization.

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 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 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.

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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