Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY
Workplace Flexibility: Field
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus.
**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.
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
- 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
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
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Competitive salaries, annual bonus and 401(k)* with company match
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Comprehensive medical, dental, vision coverage effective on start date
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24/7 Employee Assistance Program
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Free live and on-demand Wellbeing Programs
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Generous Paid Vacation and Sick Time
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Paid Parental Leave and Adoption Assistance*
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12 Paid Holidays
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On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
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Work-life integrated culture that supports an employee centric mindset
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Offers onsite, hybrid and field work environments
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Paid volunteering and charitable donation/match programs
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Diversity Equity & Inclusion Initiatives including Employee Resource Groups
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Dedicated Training Resources and Learning & Development Programs
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Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives.
$ $
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
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 www.olympusamerica.com.
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.
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.
Applicants with Disabilities:
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
