Director, Business Development Quality Assurance - Remote

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Field

 

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Job Description

The Director, Business Development (BD) Quality Assurance (QA) is responsible for strategic and tactical functional support for business development projects. This important role will be a key partner to the global BD team, ensuring that the function’s perspective is embedded in diligence and integration efforts.

Job Duties

• Serve as the global liaison between Corporate Quality and the BD team.
• Responsible for providing in-depth analysis of Medical Device/Healthcare quality management system functionality and maintenance to contribute to transfer of business activities.
• Provide strategic guidance on global QA pathways and Quality System · Accountable for developing, maintaining, and executing a QA M&A readiness plan:
  • Assess current capabilities, systems, policies, processes, organizational structure, and resources for conducting QA due diligence, integration strategy/planning activities, and integration execution against best practices.
  • Tool & Process Development and Continuous Improvement: Create the tools and standard operating processes necessary to support QA efforts throughout the full business development cycle (pre deal through integration), including ownership of assigned deliverables.
  • Develop a clear implementation plan, agreed to by BD and QA senior leaders.
• Resource planning and intra-QA coordination: maintain an up-to-date view of all projects in the business development pipeline. Plan for functional support by estimating timing and resource requirements per project. Communicate and coordinate needs within the function to identify and obtain adequate support at global and regional levels.
• Ensure the appropriate global regulatory requirements, are considered as part of due diligence and appropriately incorporated into integration activities.
• Accountable for ensuring all regulatory documentation is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies.
• Develop an understanding of business unit strategies and product portfolios. Provide Business Unit Leaders and other key stakeholders regulatory guidance strategy to assist in QA decision making, integration strategy/planning, and execution.
• Build and maintain a network of resources in all regions, across all businesses and divisions.
• Functional and Regional Alignment: coordinate with global and regional QA teams to ensure efforts are aligned, obtain approvals, and assign resources.
• Take responsibility for all QA aspects of each business development project by a) conducting or overseeing due diligence and integration activities, b) building a functional plan for each project to ensure that functional risks are identified, and actions are planned, and c) securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans.
• Stay current on industry and functional trends by reviewing the output of relevant quality and regulatory intelligence reports and apply learning to target evaluation and integration. Training & coa