Director, Business Development - Quality Assurance

March 25

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

+1 more states

🍂 Massachusetts – Remote ❄️ Minnesota – Remote 🔔 Pennsylvania – Remote

💵 $147.8k - $206.9k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Olympus Corporation of the Americas

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Olympus Corporation of the Americas is a company dedicated to developing and delivering advanced medical technology solutions aimed at enhancing healthcare throughout the patient pathway. Their mission, encapsulated in the philosophy 'True to Life', focuses on improving the standard of care to empower individuals to lead fulfilling lives. Olympus offers a range of medical systems and is also involved in educational programs to support clinical expertise and procedural skills enhancement.

5001 - 10000 employees

🧬 Biotechnology

📋 Description

• 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. • 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. • 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. • 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. • Build and maintain a network of resources in all regions, across all businesses and divisions. • Coordinate with global and regional QA teams to ensure efforts are aligned, obtain approvals, and assign resources. • 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. • 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.

🎯 Requirements

• 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); • 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

🏖️ Benefits

• Competitive salaries, annual bonus and 401(k)* with company match • Comprehensive medical, dental, vision coverage effective on start date • 24/7 Employee Assistance Program • Free live and on-demand Wellbeing Programs • Generous Paid Vacation and Sick Time • Paid Parental Leave and Adoption Assistance* • 12 Paid Holidays • On-Site Child Daycare, Café, Fitness Center**