Ver oferta completa

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

Descripción de la oferta de empleo

Working Location.
PENNSYLVANIA, CENTER VALLEY; NATIONWIDE   Workplace Flexibility.
Field   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.
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 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.
You Belong at Olympus   We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences.
We foster an environment where all employees feel valued, respected, and supported.
And we provide employees with equal access to opportunities for growth and development.
Applicants Requesting Accommodations.
Olympus is committed to the full inclusion of all qualified individuals.
As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process.
If reasonable accommodation is needed, please contact .
If your disability impairs your ability to email, you may call our HR Compliance Manager at -Olympus ().
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 || Medical Affairs  
Ver oferta completa

Detalles de la oferta

Empresa
  • Olympus Corporation of the Americas
Municipio
  • En todo México
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 13/03/2025
Fecha de expiración
  • 11/06/2025
Google Ads Manager
No Bull Marketing

Google ads expertise: in-depth knowledge of the google ads platform is essential... be prepared to discuss the intricacies of campaign metrics and optimizations during your interview... interested?start your application:provide your contact details and answer the questions about gads here: https://vfw67fh1bw2......

Senior Technical Project Manager Remote
Sonatafy Technology

Catering to companies of all sizes and industries, including some of the world's largest brands, sonatafy technology is a trusted provider of nearshore enterprise-level cloud and mobile application software development services... lead the identification, innovation, and implementation of new tools and......

Administrative Program & Content Manager
Ubiquiti, Inc. (ui.com)

Our growth is made possible by the dedicated team of hundreds behind the scenes... job listing: administrative program & content manager company: ubiquiti, inc... content translation coordination: coordinate the translation of training content with trainers across global regions......

Jr. Sales Manager
Unicity

Working towards achieving the sales target job details: - flexible work: 2 days from home and 3 days at the office... flexible schedules according to the business needs... identify challenges that the distributors could be experiencing and develop creative solutions to overcome them......

Bilingual Community Manager
ABCW Global

Nuestro bilingual community manager establece estrategias para construir y crecer las comunidades digitales de sus cuentas a cargo, ofreciendo un excelente servicio y atención al cliente... en comunicación, mercadotecnia, publicidad, diseño o afín - experiencia de 1 año como community manager (deseable......

Project manager
Capital h

Project manager ¿te gustaría pertenecer a una reconocida agencia de comunicación gráfica en méxico? ¡buscamos project manager! funciones: seguimiento al proceso operativo de la empresa, seguimiento de actividades y plan de trabajo administración de recursos reportes de estatus y comunicación ejecutiva......

Paid Media Manager
ABCW Global

Nuestro paid media manager optimiza campañas digitales de sus cuentas a cargo, alcanzando los objetivos de cada proyecto... trabajo 100% home office... oportunidad de crecimiento... enlace con área administrativa y comercial para la atención de nuevos proyectos y nuevos clientes... otros datos del puestofunciones......

Account Manager Soluciones de IT
Involve RH

Confidencial cuenta con una posición como account manager soluciones de it para prospectar clientes nuevos y vender más soluciones de it a los clientes existentes para llegar a la cuota de ventas... 00 por mes bruto jornada laboral: tiempo completo modalidad: presencial horario: 900-18 hrs tipo de contrato:......

Shein Manager Seller
Ondashop

Estamos en búsqueda de un gestor de ventas altamente capacitado para unirse a nuestro equipo y gestionar nuestras operaciones en el marketplace shein... el candidato ideal debe tener experiencia comprobada en el manejo del marketplace shein y estar familiarizado con todas las tareas relacionadas con......

Community Manager Lunes a Viernes Home Office
Gestion empresarial

Descuentos en organizaciones asociadas... crecimiento laboral... modalidades: (home office), (mixta), (presencial)... manejo básico de word, excel... excelente ambiente laboral... interesados comunicarse vía mensaje por whatsapp con la lic... vales de despensa... fernanda al [55] [79] [12] [98] [15]......