Senior Manager, Combination Products & Medical Devices

About the role

The Senior Manager, Combination Products & Medical Devices is responsible for representing QA on cross-functional teams and ensuring products comply with worldwide Combination Product and Medical Device Regulations.

Responsibilities

• Manage and oversee 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.
• 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. 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 third-party supplier management activities such as review and approval of third-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.

Requirements

• 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.

Qualifications

• Bachelor's degree 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.

Skills

• Leadership skills and ability to take a position on Quality issues and standards.
• Sound technical understanding of product development and design control.
• Well-versed in risk management methodologies.
• Strong analytical approach to identifying problem areas and effective solutions.
• Ability to work independently and in a global team environment.

Benefits

• Coverage of medical/dental/vision insurance.
• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Participation in long-term incentive programs.

Pay

$124,500 - $236,500 USD

Schedule

Primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.