Working Location: PENNSYLVANIA, CENTER VALLEY

　　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 IT Validation Leader is responsible for supporting the management of system and software validation checks of systems against regulatory requirements. They will assist in monitoring the compliance of system adherence to good practice guidelines and regulations from creation of a medical device through to authorization to ISO standards (e.g., GMP, GCP, MDR etc.). They will also work closely with the QARA domain who will be assisting in the conduct of validation software/ systems.

　　The IT Validation Leader will assist with managing the relationship with the external vendors (where applicable) for ensuring the conduct of validation of the software/ systems to ensure that they are regulatory compliant and advocate traceability, transparency, and robustness through additional testing. They will also be responsible to provide oversight that projects/ products and platforms governance is adhered to by teams and documentation is kept updated periodically. The IT Validation Leader will provide feedback on adherence to regulatory compliance on changes presented via Change Advisory Boards. In addition to this, they will also ensure changes are implemented by using IT change governance processes. They will re-validate systems during change periods (incl. both major and minor changes) to ensure regulatory compliance as well as conduct spot check audits to ensure projects/ products/ platforms change governance is adhered to.

　　“The job is conducted in line with our Core Values which are: agility, empathy, long-term view, unity and integrity.

　　Olympus is an equal opportunities employer championing a culture of equality, diversity and inclusion embedded throughout the organization and workforce.”

　　Job Duties

　　Development of a Global Validation Framework:

　　Develop the cross-regional validation strategy of utilizing and leveraging support from a third party/ external resources.

　　Review and validate third party vendors/ external resources to create a partnership to support the cross-regional validation strategy.

　　Develop and manage the IT validation and change management roadmap to ensure efficient and effective resource management against the validation activities required across all regions.

　　Change Management:

　　Review documentation for projects/ products and platforms to ensure governance is adhered to by the external and internal teams.

　　Take part in scheduled CAB sessions and provide feedback on adherence to regulatory compliance.

　　Provide an overview to ensure changes implemented are following IT change governance processes.

　　Manage spot check audits to ensure projects/ products/ platforms change governance is adhered to.

　　Organization of internal GxP trainings for software validation (where applicable):

　　Design, implement and manage all operational validation activities within the Global IT organization.

　　Provide guidance to Global IT teams on the process for the creation of validation documentation and requirements including (but not limited to) the following: Computer Systems Validation Plans & Quality Control Validation Plans.

　　Liaise with the QARA domain to provide updates on the execution and outputs of the validation conducted for software/ systems.

　　Job Qualification

　　Required:

　　Bachelor’s degree in Life Science, Computer Science or Business (or related field).

　　At least 5 years in validation, preferably with a focus on pharmaceutical, biotechnology, clinical, medical, laboratory or other applicable area.

　　Experience in quality risk management and handling GxP regulations.

　　Experience in project management especially with regards to CQV.

　　Progressive experience in a multi-national, multi-divisional technology environment with demonstrated experience in planning, forecasting, modeling, and analysis.

　　Knowledgeable in Quality Systems and be considered a Subject Matter Expert (SME) in several CQV capabilities (manufacturing, facilities, utilities, and computer systems validation).

　　Good understanding and application of FDA and regulatory requirements.

　　Experience in successfully managing a small team.

　　Preferred:

　　Demonstrable technical communication.

　　Demonstrable analytical and conceptual thinking.

　　Detail orientated.

　　Other Considerations (travel/hours availability, etc.): N/A.

　　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) || Pennsylvania (US-PA) || Center Valley || Information Technology (IT)