hero

Opportunity is here

186
companies
1,250
Jobs

Vice President Business Development & Strategic Programs, Quality Management

Olympus Medical Systems

Olympus Medical Systems

Sales & Business Development, Quality Assurance
Westborough, MA, USA
Posted on Thursday, November 30, 2023

Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Hybrid

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 Vice President, Business Development Quality will organize and oversee the Quality, Regulatory Affairs and Compliance activities in support of Business Development process. This role would be responsible for orchestrating and execution of due diligence activities, deal assessment, remediation, and integration planning for potential business development opportunities. These may include a range of potential deals ranging from technology development agreements and distribution deals to full acquisition of small, medium, or large operating businesses and integration of those into Olympus operating environment. The role would be responsible for identification and assessment of risk, estimation of resources and funding required to remediate and integrate and ultimately for a recommendation to the business. This role will lead a BD Quality Organization and will work within the broad global Quality organization to ensure that appropriate experts from the broad organization participate in assessment and integration planning and ensuring that smooth integration into Olympus Quality System occurs.

The following roles will report into this role directly: Director Business Development Quality, Sr. Manager Business Development Quality, Sr Quality Auditor, other Director / Sr. Manager roles involved with integration based on ongoing integration initiatives.

This role will be responsible for development of the BD/Integration Quality Plans, resourcing and execution of those plans to completion and ultimately for Quality and Compliance operation of the acquired entities or BD deals.

The Vice President, Business Development Quality will work closely with other functions within and outside of the Quality and Regulatory organizations such as Operations, Service/Repair, R&D, Post Market Quality, Medical Affairs, Legal and others to ensure that the Quality strategy and operating objectives of the Business Development organization are designed in support of the company and Quality/Compliance objectives.

Job Duties

  • Ensuring that a BD playbook and other functional infrastructure is developed and continuously improved ensuring thorough and risk-based approach to the BD activities.
  • Act as the primary point of contact between Quality and BD for all BD related activities and projects.
  • Developing and execution of the Quality Plans in support of BD activities.
  • Resource and financial assessment of integration timing and resulting expenses.
  • Evaluation of risk (Quality and Compliance) associated with each BD activity and ultimate recommendation to the BD organization regarding each BD action.
  • Building and maintaining a strong linkage with the rest of the Olympus organization within the Quality and across other functions.
  • Development and execution of post deal Integration Quality plans.
  • Design and implementation of effective Quality System for acquired targets aligned with the Olympus Quality Management System.
  • Develop strong and transparent KPIs to oversee and assess Quality and Compliance performance across all acquired entities.
  • Ensuring, achieving, and maintaining a strong state of regulatory compliance for acquired entities including management of registrations and regulatory compliance audits.
  • Improve and maintain a Patient Safety, Compliance and Customer focused Quality Mindset throughout the organization.
  • Develop and maintain a Business Development Playbook
  • Manage and develops Quality organization in support of Business Development activities.
  • Develop and execute Quality Plans to support early BD and Integration activities.
  • Complete and communicate risk assessments based on Quality, Compliance, Timing and Funding impacts for Business Development activities.
  • Manage and ensure audit readiness for acquired entities until their transition into baseline Olympus operations.
  • Orchestrate and complete integration activities in coordination with all relevant functions within the Olympus organization.
  • Tracks and improve Key Quality and Compliance Indicators for acquired entities.
  • Assess, Design, and Develop Quality organizations for acquired entities to ensure strong focus on Safety, Quality and Compliance.
  • Represent Quality on BD leadership teams.
  • Set and improve Quality Culture and Mindset across acquired entities to ensure cohesive transition into full integration of those into Olympus operations.

Job Qualifications

Required:

  • Minimum requirements are a BA/BS degree or equivalent in Engineering or Physical Science with an advanced technical degree and MBA preferred.
  • Minimum of 12 to 20 years of experience in quality management or compliance function with at least 5-7 years of management experience in a global position in a regulated environment in the MedTech industry.
  • Strong prior experience in Business Development initiatives including Due Diligence, Risk Assessment and Integration activities.
  • 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, GCP, HIPAA.
  • Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.
  • Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as up to 50% travel should be expected.


Preferred:

  • Experience with durable medical equipment and sterile disposable medical devices within Med Tech industry is strongly preferred.
  • Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.
  • Excellent written and oral communication and organizational, project management skills.
  • Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
  • "Out of box" strategic thinker with strong leadership ability.
  • As a change agent, motivated to improve organization and not be satisfied with status quo.
  • Experienced in initiating, cultivating and embedding a cultural change in a complex and diverse Olympus organization.
  • Excellent interpersonal and leadership skills with diverse cultural approach.
  • A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus.
  • Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
  • Excellent writing and verbal skills


#LI-Hybrid

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.

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