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.
· 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 (Design Control) 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.