Program Manager (Quality & Regulatory Affairs) - Remote

Working Location: CALIFORNIA, SAN JOSE; Nationwide
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.

Plan and direct the execution of complex quality programs and projects across the global quality team relating to product improvement, process standardization or improvement, cost reduction, integration and regulatory compliance within the assigned portfolio. Responsible to directly, and indirectly lead cross-functional teams in the execution of end-to-end programs and project plans. This will include business case evaluation, budget analysis, resource requirements, detailed timelines, and risk assessments at the project and program level.
Job Duties

• Serves on PMO and Project Steering Committees and provide regular project updates (written and verbal) to appropriate management and Olympus governing boards.
• Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.
• Work with executive sponsors, business partners, global and regional teams, and subject matter experts to define project scope, structure, project plan and timeline.
• Manage internal and external vendor relationships, including contract initiation and amendments, PO and budget, and vendor performance.
• Monitor project progress and report on project progress, problems, solutions. Identify and report project risks and initiate, implement and follow-up on counter measures.
• Define project plans including timeline, milestone, budget, and resources. Ensure project deliverables (incl. documentation, reporting of relevant project results etc.) are successfully completed through alignment and collaboration with customers and stakeholders.
• Lead value-add activities, such as hosting GIMBA walks, leading Kaizen events, facilitating pre-and post-mortems, and designing/facilitating brainstorming sessions.
• Identify project goals and project deliverables in collaboration with project sponsor as well as relevant stakeholders and define project approach.
• Directly manage specific projects and programs, as assigned. Leads large/complex projects and leads the project team. Lead multiple projects concurrently and/or some programs.
• Focus on successful steering of diverse projects & programs in alignment with organizational goals.
• Plan and ensure continuous communication, involvement, and alignment of all relevant stakeholders.
• Steer and monitor time, cost, people and quality within the managed projects as well and perform controlling and monitoring of financial aspects.

Job Qualifications
Required:

• Minimum of 8 years of experience in project management or technical experience in the medical device field or any other regulatory controlled industry.
• Bachelor’s or master’s degree or equivalent
• Ability to manage multiple projects and deadlines with competing priorities in a fast-paced and evolving work environment with a demonstrated track record of execution is required.
• Many years in complex projects or programs including first experience in portfolio management.

Preferred:

• Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
• Must have excellent influencing skills, communication skills, presentation skills and team oriented.
• Must have the ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.
• Experienced in strategic planning and risk management.
• Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
• Lean Six Sigma certification, preferred.
• Can build rapport, influence without authority, and motivate teams without direct management authority.
• Experience working with multi-disciplinary senior leadership members and analyzing, clarifying and translating business requirements into functional and technical specifications is a plus.
• Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
• Highly proficient in Microsoft Word, Excel, PowerPoint, Visio, Project, PowerBI experience preferred.
• MS Project and project management tools.
• The ability to lead and manage remote teams in both global and regional environments.
• Ability to understand business needs/requirements and system capabilities to develop efficient and effective solutions.

Why join Olympus?
Here, people matter—our health, our happiness, and our lives.

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

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 .
The anticipated base pay range for this full-time position working at this location is $115,026.00 - $161,036.00 / 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 ncluding: level of experience, working location, and relevant education and certifications.
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.
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) || California (US-CA) || San Jose ||