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Director, Business Development - Quality Assurance

Req ID:  6163


Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.


Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.


Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View


We deliver on our purpose and our core values by staying True to Life.

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 & 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 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); domestic and international.


* Experience with global submissions and determining regulatory pathways.


* 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

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations


We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.  For more information, visit


Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.


Let’s realize your potential, together.

Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.


It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.


Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || 

Nearest Major Market: Worcester

Job Segment: Medical Device Sales, Medical Sales, QA, Quality Assurance, Business Development, Sales, Technology, Quality

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