Job Description

Working Location: ONTARIO, RICHMOND HILL

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.



The IT Validation Lead is responsible for managing the IT Validation capability within the IT Assurance function. They are responsible for owning the system and software validation checks of systems against regulatory requirements. They will monitor 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 own the relationship with the QARA domain who will also assist in the conduct of validation software/ systems.

The IT Validation Lead will manage 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 Lead will provide feedback on adherence to regulatory compliance on changes presented via Change Advisory Boards. In addition to ensuring changes that 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 conducting spot check audits to ensure projects/ products/ platforms change governance is adhered to.

\xe2\x80\x9cThe 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.\xe2\x80\x9d

Job Duties

• 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.

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

• Work closely with all Global IT functions to ensure the operation of validated environments (according to GMP and other regulatory requirements relevant to a MedTech company).

• Perform the initial Quality Gate Check when a new application / SW is introduced to determine whether the software needs to be validated or not.

• Provide guidance to Global IT teams on the process for the creation of IT validation documentation and requirements.

• Support project leads in preparing the functional specifications and conducting the validation report and testing when required.

• Provide expertise and advice to Global IT programs and projects on validation.

• Support the revalidation process in the event of a major change.

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

• Manage the relationship with the external vendors (where applicable) to ensure the conduct of software/ system validation is completed accurately to be regulatory compliant.

Job Requirements

REQUIRED QUALIFICATIONS:

• Bachelor\'s degree in engineering, Chemistry, Life Science (or equivalent and related experience preferred).

• At least 7 years in validation, preferably with a focus on pharmaceutical, biotechnology or other applicable area.

• Experience in quality risk management and handling GxP regulations, project management especially with regards to CQV.

• Minimum 5 years\' experience in a leadership role.

PREFFERED QUALIFICATIONS:

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

• 3-5 years of experience managing and building teams.

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

• Experience in both managing people and processes, and in leading, supporting and mentoring a team.

*

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, Caf\xc3\xa9, 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 .

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 .

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 \xe2\x80\x9cfully vaccinated\xe2\x80\x9d 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: || Canada (CA) || Ontario (CA-ON) || Richmond Hill ||

Olympus Corporation