Job Information
Olympus Corporation of the Americas Sr. Manager of Global BPO Services - Remote in Center Valley, Pennsylvania
Working Location: CALIFORNIA, SAN JOSE
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
As the Sr. Manager of Quality & Regulatory Compliance, you will lead compliance related activities for business integration projects, manage External audits (i.e. FDA, Notified Bodies) for various Olympus sites in the Americas region, develop and deliver audit and SME training, audit preparation and orchestration. Establish and deploy audit readiness preparation at all Olympus sites in the Americas. As necessary, you will supplement Internal Audit. Lead the tracking and trending of compliance metrics to ensure adherence. Champion or partner with key business stakeholders at various sites to identify and implement QMS improvements.
Job Duties
Implement proactive compliance initiatives and provide guidance to the sites in the Americas region, including support for Quality improvement and remediation activities
Manage the external inspections and audit management for various sites across the Americas, which will include site inspection/audit readiness, execution and follow-up
Partner with Site Management Representatives and Process Owners to ensure that prompt corrective actions are taken in response to identified gaps or systematic risk, including the development of corrective action plans, as needed
Institute and maintain an effective compliance communication program for the organization and understanding of new and existing compliance issues and related policies/procedures
Collaborate to develop the technology infrastructure needed to support quality improvement programs, participating in the design and implementation of data collection
Ability to lead direct and indirect resources and build and develop team
Serve as Lead Auditor or Team Member for Internal Audits, as needed
Provide support and expertise to FDA inspections occurring at other Olympus globally, as needed
Develop metrics and compile data on audit results, issues or trends and corrective actions and present to senior management; and develop and deliver required trainings
Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards. Ensure results of monitoring process are routinely communicated to management through periodic review process
Assure all external auditing companies meet internal requirements prior to executing any portions of the contracting agreement
Standardize and leverage compliance policies, practices, metrics and resources across sites. Serve on cross-site project teams consistent with company objectives to improve overall compliance performance to established requirements and metrics
Research emerging regulatory trends and changes in regulations and standards to incorporate into the business; ensure ongoing compliance to these requirements
Lead or support special quality and compliance projects as requested, and perform other duties as assigned by management.
Job Requirements
Education*:
A minimum of a 4-year college degree (Bachelor’s Degree) or equivalent in a technical or science-related field is required
Master’s Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline
Experience*:
A minimum of 7 years of professional experience in the medical device or pharmaceutical industry is required
A minimum of 5 years of auditing experience in a medical device or pharmaceutical environment is required
A minimum of 3 years of functional management or technical leadership experience is required
Skills:
Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, SOR 98-282 CMDR (Canada), J-PAL (Japanese), European Medical Devices Directives, European Medical Devices Regulations, ANVISA 16/2013 (Brazil), TG(MD)R Sch3 (Australia), and any other regulations or standards applicable to the site is required
Proven leadership, teamwork, collaboration and influencing skills; demonstrated initiative and assertiveness; strong project management skills; strong computer skills and use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint); strong written and oral communication skills, are required
Certified Quality Auditor (CQA) or Certified Lead Auditor is required
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 .
The anticipated base pay range for this full-time position working at this location is $114,213.00 - $159,898.00 / 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 including: 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.
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 || Quality & Regulatory Affairs (QA/RA)