Senior Manager, Combination Products & Medical Devices

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 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 as appropriate, biologics regulations.  Responsible for compliance with company policies and procedures.
• Perform design control activities:  Mentor/lead product team members through the design process providing guidance.  Work closely with research organization to ensure potential product issues are identified and addressed in the design.  Assure robust product vs. customer requirements.  Ensure interfaces to drug development where appropriate.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.  Assess the impact of a change on the 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 3rd party supplier management activities such as review and approval of  3rd party design control activities, assessment of supplier changes, establishment of appropriate balance between internal oversight actions and supplier controls, provide input to quality agreements, perform relationship development, supplier site visits, etc. Support supplier audits as required.  Partner with Third Party Vendors/Manufacturers/Laboratories to ensure that combination products/devices are in compliance 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 team member in global and local product development teams for Combination Products to proactively avoid, or appropriately address quality-related issues.
• Provide consultation & 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.
• 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 3rd 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 have been seen to take a position on Quality issues and standards, and must be capable of clearly and logically justifying such positions.
• Sound technical understanding of product development (e.g., approaches for definition of 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, influencing, 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.

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html