Senior Manager Customer Quality Compliance Operations

at  Olympus Corporation of the Americas

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.

JOB DESCRIPTION

The position leads cross-functional team to investigate and develop responses to internal and external audit findings and observations, including3rd party and regulator audits. The position will be responsible for reviewing and authoring all Customer Quality external audit responses prior to submission to corporate compliance and / or regulators. The position will ensure adequate tracking and monitoring of all external and internal Customer Quality commitments to facilitate timely implementation and completion of actions, and will also provide routine progress updates and escalation of potential compliance issues to functional and site leadership respectively. The position will provide guidance, training, and coaching to team on quality compliance matters including on communication during audits and in responses.

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.

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.
**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 DUTIES

• Implements and maintains the Customer Quality external and internal audit response process and activities.
• Monitors for timely completion of applicable Customer Quality commitments to US FDA, and other Regulatory Authorities as applicable.
• Leads cross site / functional teams on investigating, assessing, and developing strategy for internal and external responses.
• Reviews and authors responses prior to submission to Corporate Compliance and/or regulators
• Tracks, trends, and analyzes audit findings, corrective actions, and remediations; provide inputs to upstream processes for improvements.
• Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advises management on potential improvements or enhancement to quality systems and processes in the company.
• Develops new approaches to solve problems identified as part of the team.
• Participates in the implementation of Global Customer Quality initiatives and programs as required.
• Participates in the CAPA process as required as an assignee or project team member.