Executive Director, Business Development & Strategic Program, Quality Management

Job title: Executive Director, Business Development & Strategic Program, Quality Management

Company: Olympus

Job description: Working Location: PENNSYLVANIA, CENTER VALLEY; NATIONWIDEWorkplace Flexibility: FieldFor 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..**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 DescriptionThe Executive Director, Business Development Quality will organize and oversees 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, Director, Business Director Regulatory Affairs, Sr. Manager Business Development Quality, Sr. Quality Auditor.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 Executive Director, 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 the Quality strategy and operating objectives of the Business Development organization are designed in support of the company’s Quality/Compliance objectives.Job Duties

• The ED, Business Development Quality, will focus on building and developing the following key competencies and processes:
• 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/Regulatory Affairs 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 maintain strong linkage with the Olympus organization within 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 monitor Quality and Compliance performance across all acquired entities.
• Maintaining a clear view of Olympus standards of QARA and represent their consolidated view on QARA standards of each target to functional leadership as part of pre-deal planning.
• 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 QualificationsRequired:

• Minimum requirements are a BA/BS degree or equivalent in Engineering or Physical Science with an advanced technical degree and MBA preferred.
• Minimum of 10 to 12 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.
• Skills:
• 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

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:Competitive salaries, annual bonus and 401(k)* with company matchComprehensive medical, dental, vision coverage effective on start date24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance*12 Paid HolidaysOn-Site Child Daycare, Café, Fitness Center**Connected Culture you can embrace:Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsDiversity Equity & Inclusion Initiatives including Employee Resource GroupsDedicated Training Resources and Learning & Development ProgramsPaid Educational Assistance*US Only**Center Valley, PA and Westborough, MAAre you ready to be a part of our team?.The anticipated base pay range for this full-time position working at this location is $137,913.00 – $206,869.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.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 .Olympus is dedicated to building a diverse, inclusive and authentic workplaceWe 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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

Expected salary: $137913 – 206869 per year

Location: Center Valley, PA

Job date: Sun, 21 Jul 2024 02:30:08 GMT

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