Senior Manager, Business Development Quality Assurance

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

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 Sr. Manager, Business Development Quality Assurance will support Quality Assurance M&A activities throughout the project lifecycle.

This role will participate in due diligence of targets and identification of potential compliance risks which could impact the business.

The Sr. Manager will identify resourcing and budgeting needs to effectively mitigate the identified risks. This role also participates in transition service planning, integration planning, and integration execution post-close to ensure a smooth transition and integration into Olympus Quality System occurs.

This role will be responsible for development of Integration Quality Plans, training, and execution to those plans which requires close collaboration with the Quality Assurance sub functions.

Job Duties

• Perform due diligence and communicate Quality Assurance risks associated with the target.
• Define and evaluate compliance risks and develop mitigation plans to address the risks.
• Identify resourcing and budgeting needs to appropriately mitigate risks; communicate these needs to the Quality Assurance BD Lead & BD core team members to be included within the deal model to ensure effective execution of risk mitigation activities.
• Develop quality plans for integration into the Olympus Quality Management System following M&A.
• Train the integration team to the execution of integration quality plans
• Support the functional integration leaders during integration planning and execution.
• Utilize the BD playbook to develop Quality integration plans and communicate suggestions for continuous improvement.
• Work cross functionally with Olympus team members supporting Business Development activities to ensure system integration.
• Build and maintain a network of resources in all regions, across all businesses and divisions.
• Integrate the target site into the Olympus quality culture and ensure cohesive transition into full integration. Stay up to date on the latest global regulations.
• Collaborate closely with the Quality, Regulatory, R&D, Business Development, Medical & Scientific Affairs, IT, and Operations functions.
• Other BD project related tasks and deliverables as determined by the Quality Assurance BD Lead.

Job Qualifications

Required :

• Minimum requirements are a BA / BS degree or equivalent in Engineering or Physical Science with an advanced technical degree and / or MBA preferred.
• Minimum of 10 years of Quality Assurance experience in the Pharmaceutical or Medical Device industry (Medical Device preferred).
• Strong prior experience in Quality Assurance initiatives including post market surveillance, complaints management, quality KPls, Design Controls, Risk management, CAPA, Quality Management Review, Audits, and Supplier Quality.
• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry such as : ISO, QSR, GMP, GLP.
• Experience in Business Development M&A projects including due diligence, integration planning, and project management.
• Travel : Position requires up to 20% travel both domestic and international.
• Experienced in strategic planning and risk management.
• The ability to lead remote teams in both global and regional environments.
• Experience in Business Development M&A projects including due diligence, integration planning, and project management.

Preferred :

• Excellent written and oral communication and organizational skills.
• Ability to adapt to a changing environment.
• Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.

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 https : / / www.olympusamerica.com / careers / benefits-perks .

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 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)