Director

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
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 & coaching: Develop personal expertise and train QA personnel on BD tools & processes. Coach colleagues on how to effectively participate in due diligence and integration planning and execution.
Job Qualifications
Required:

Bachelor’s degree in a science-related discipline; Masters preferred.
Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of 10 years in a global role.
Potential for travel up to 30% (deal-needs dependent); domestic and international.
Knowledge of and experience managing a Quality Management System and leading external QMS certification/surveillance audits.
Thorough understanding of global submission requirements and appropriate design control requirements in order to satisfy global Health Authority submission standards.
In-depth knowledge of global quality and regulatory requirements for the development of new product and maintenance support for sustaining market access.
Experience in Business Development/M&A projects including due diligence and post-merger integration.
Demonstrated ability to work cross-functionally.
Demonstrated ability to lead programs/projects. Has sense of passion, drive and perseverance to accomplish goals. Excellent team player.
Global understanding of product domains and key technology/therapeutic area/R&D disciplines
Excellent leadership and interpersonal skills, including the ability to work across cultures and personality types
High business acumen: ability to learn quickly and adapt to new circumstances; comfort and ability to effectively order the unknown; intellectual agility
Excellent communication skills, both verbal and written; ability to quickly distil complex information into actions/recommendations
Excellent ability to read and influence senior decision makers bridging organizational complexities
Strong project management skills, including planning, budgeting, and resource management
Excellent understanding of the typical functional roles and responsibilities in R&D
Practical understanding of global regulatory/quality standards and requirements