Director, Global CAPA Community of Practice Lead - Remote Job at Olympus Corporation of the Americas
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Job Description
The Global CAPA Community of Practice Lead provides expertise and shares best practices regarding quality tools, problem solving methodologies for effective CAPA compliance to international regulations and standards.
Responsible for the promotion of a global CAPA mindset on problem solving methodologies and risk assessment through skill enhancement and developing education models for the Olympus global businesses.
This position will be responsible for the transformation of CAPA training practices, coaching of CAPA owners, mentoring of CAPA co-Ordinator’s, defining roles and responsibility in review boards through a community of practice that connects, influences through strong analytics insights, communication strategies and visualization tools. This position is responsible for managing and implementing identified community outreach activities to global partners on CAPA for ‘how to be effective’ and CAPA recognition on ‘adding value’.
Job Duties
- Exhibit high energy and engagement in identifying and pursuing partnerships with Stakeholders in driving and delivering strategies for Olympus Global CAPA Community of Practice business model.
Champion of CAPA ownership, timely execution, and effectiveness of CAPA’s. This includes enhancing skills in creation, collaboration with functional teams on Problem Statement writing/Scope identification/Risk Assessment/Containment/Correction/CAPA plans/Verification of local and global compliance to CAPA procedures to ensure timely effective closure of CAPAs.
Applies strategic and critical thinking to identify solutions to non-standard requests and complex problems.
Consult and advice leadership on process and performance improvement opportunities that will foster growth, improved data analytics and operational efficiencies.
Drive dynamic leadership in motivating and inspiring team members to deliver the best in impactful change management for compliance, robust process, proactive improvement culture and delivering results.
Analyses and solving complex solutions which require novel and new innovative approaches or technology enhancements and global adoption.
Facilitate and participate in internal and external Quality Audits (including notified bodies and health authorities).
Is the resident expertise in the application of Quality Tools including, Change management, Stakeholder engagement, statistics, data analysis, process mapping, problem solving, root cause verification and the creation of next generation infrastructure CAPA solutions.
Deputize for CAPA GPO and perform Other Essential Duties as assigned by Management.
Job Requirements
REQUIRED QUALIFICATIONS:
Bachelor of Science, medical, engineering, or scientific discipline; Six Sigma, Lean Manufacturing and Continuous Improvement skills
Minimum of 10 years’ experience in a drug/device manufacturer with demonstrated results in effective developing strong collaborative community of practices for QMS to International Regulations and standards.
Demonstrated community and stakeholder engagement to measure the direct and indirect impact of the community relations activities.
- Demonstrated experience in developing and leading qualification programs and continuous assessment for Cultural Change.
- Demonstrated lead in creation, soliciting buy-in and delivering advanced technological solutions.
Up to 30% international travel. Fluency in English
PREFERRED QUALIFICATIONS:
Managed multiple priorities to meet deadlines and work independently.
- Competent understanding of International medical device/drug regulations specific expertise in; Regulatory Inspections, CAPA policy development & implementation, Mentoring and Coaching of teams, Strong analytics driving proactive solutions and demonstrated enhancements on quality engineering principles.
- Competent with Microsoft Office 365 Suite, Visio, Adobe, DocuSign, Agile and Windows platforms.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.
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) || Massachusetts (US-MA) || Westborough ||
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