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Senior Manager Customer Quality Compliance Operations
3 months ago
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.
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.Job Qualifications
Required:
Bachelor’s degree in a science, engineering discipline, or equivalent A minimum of 10 years of related professional experience in the medical device industry. Experience in authoring and managing communications to regulatory agencies. Experience working with, presenting to and communicating with executive leadership. Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485,Health Canada, MHLW, ANVISA, and TGA. Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits. Experience writing, reviewing, and providing feedback on requests for additional information or audit responses. Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations. Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. International travel up to 25% of the time should be expected.Preferred:
Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D,Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc.…). Proven leadership, teamwork, collaboration and infl uencing skills. Ability to work eff ectively and with agility in a fast paced and dynamic environment. Working knowledge of problem-solving skills good statistical and analytical skills. Strong written and verbal communication skills. Proficient in the use of Information Technology. Fluent in English language 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