CLINICAL QUALITY ASSURANCE MANAGER JOB DETAILS | OLYMPUS CORPORATION OF THE AMERICAS

Working Location.
PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK   Workplace Flexibility.
Hybrid   For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
​ ​ ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
​ Our five Core Values empower us to achieve Our Purpose.
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus.
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Job Description The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical Quality Assurance and provides support to ensure the quality and compliance of studies conducted throughout Olympus.
This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency regulations and standards, GCP, Industry guidelines, and Olympus policies and processes for the conduct of clinical studies.
Job Duties Maintain, and monitor Olympus GCP processes and procedures for compliance with applicable regulations and industry best practices, participate in clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents (e.
.
SOPs, Work Instructions, Templates).
Lead or assist with the implementation of Quality processes audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and/or ISO standards where applicable.
Lead or contribute to the development and maintenance of key Clinical Quality metrics for input into process improvement initiatives and/or presentation to Study Management Teams and Senior Leadership.
Lead the development and delivery of clinical quality and compliance related training to internal functional groups.
Provide guidance internally and ensure study teams are following targeted SOPs during a study.
Assist in development of risk based GCP audit strategies across clinical programs and/or studies.
Plan, develop and manage audits of clinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities (e.
., reports, corrective actions).
Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulation, including Quality Control checks of the eTMF to ensure it is inspection ready.
Assure appropriate oversight of the Computer Software Validation program.
Assure appropriate oversight of the Vendor Qualification/Management program.
Assist in conducting audits, risk assessments and inspections of clinical study vendors.
Work with vendors and support personnel in eliminating problems via root cause analysis techniques to continuously review and improve existing processes.
Work closely with the Olympus Quality organization to support audit /inspection readiness activities and responses; driving process improvements as needed.
Other duties as assigned.
Job Qualifications Required.
BA/BS degree in life sciences or related field (i.
., Biomedical Engineering) Minimum of 7 years of experience working in clinical quality assurance/operations roles (medical device industry strongly preferred) Minimum of 10 years' experience in medical device or pharmaceutical industry Solid knowledge of ICH-GCP, applicable global clinical regulations and guidelines, and quality principals (ISO , ISO , and ISO knowledge).
Direct experience interacting with FDA and/or other health authority inspections of sponsor, investigator site(s), and/or CRO(s).
Ability to represent the company in audits, coordinating responses with legal, clinical development, and outside vendors where applicable.
Experience auditing clinical vendors, Clinical Research Organizations (CRO) and internal clinical programs.
Experience leading, developing and/or implementing Inspection Readiness Programs and associated activities.
Experience in managing inspection and post-inspection follow-up activities.
Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.
Strong analytical and problem-solving skills, with a focus on risk management, validation, and continuous improvement.
Previous experience of CTMS, eTMF and EDC Systems  Domestic and international travel up to 15% Availability in the morning/evening for global meetings (occasionally) Why join Olympus?   We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on.
Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center**   Connected Culture you can embrace.
Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Diversity Equity & Inclusion Initiatives including Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance   *US Only   **Center Valley, PA and Westborough, MA     Are you ready to be a part of our team?   Learn more about our benefit and incentives.
The anticipated base pay range for this full-time position working at this location is $ / 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.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling.
As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 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 employees throughout locations in North and South America.
For more information, visit www.
lympusamerica.
om.
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.
Applicants with Disabilities.
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone.
If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at .
If your disability impairs your ability to email, you may call our HR Compliance Manager at -Olympus ().
Posting Notes.
|| United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs