- 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.g. 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.
- 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 closely with the Olympus Quality organization to support audit /inspection readiness activities and responses; driving process improvements as needed.
- Other duties as assigned.
- BA/BS degree in life sciences or related field (i.e., 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.
- 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)
- 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, Fitness Center**_*US Only_
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Clinical Quality Assurance Manager - Center Valley, United States - Olympus Corporation of the Americas
Description
Working Location:
PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK
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
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
Plan, develop and manage audits of clinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities (e.g., reports, corrective actions).
Work with vendors and support personnel in eliminating problems via root cause analysis techniques to continuously review and improve existing processes.
Job Qualifications
Required:
Why join Olympus?
_Here, people matter-our health, our happiness, and our lives._
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.
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._
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 1-888-Olympus
Posting Notes:
|| United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)
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