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Global Vice President QARA Compliance

Req ID:  4183

Working Location: MASSACHUSETTS, WESTBOROUGH 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Global Vice President QARA Compliance provides assurance and manages all aspects of Regulatory Compliance. The focus will be over the implementation of the Global Quality Systems Processes, compliance with FDA CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements.

 

The Global Vice President QARA Compliance is responsible for executing a global compliance audit program of the quality management system, providing assurance of the effectiveness of the Quality and Compliance of the organization, which is designed to meet appropriate division, Olympus, government, and international standards/regulations for efficacy, safety, quality and compliance for the design, manufacture, and service of clinical and research products.   


The Global Vice President QARA Compliance will focus on five primary areas that will influence how the functional vision and implementation plans align to the business strategic imperatives and global function mission.

1.    Global Audit Planning for Internal and External Audit Activities
2.    Review and Approve all Official Audit Responses to External Regulatory Authorities  
3.    Improving Efficiency in Audit Execution and Reporting to Executive Management 
4.    Accelerating Talent Development 
5.    Driving Risk Based Assurance and Monitoring utilizing data  

Job Duties

* Thinks “Out of the Box” to optimize Corporate Quality goals and business value & plans, directs resources and activities with Corporate Quality. 

 

* Develops and implements global compliance strategies, oversees all aspects of risk assessment development.

 

* Ensures alignment of compliance activities to business activities with global a focus on Growth, Innovation, and Operational Effectiveness across all functional areas.

 

* Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions and remediations.   

 

* Administer and manage supplier qualification activities and monitor suppliers’ performance and provide recommendations.  

 

* Coordinates and leads audit activities with all global regulatory agencies (e.g. FDA, Notified Bodies, PMDA, NMPA etc.) 

 

* Creates and maintains Compliance department internal methodology and procedures that comply with applicable domestic and international regulatory laws/standards and all developed Olympus policies and procedures. 

 

* Mentors, manages, and develops direct reports.

 

* Develop and deliver Compliance monitoring scorecards to Executive Leaders for real time reporting on Quality Management System

 

* Mentors, manages, and develops direct reports. Trains key personnel on quality policies, processes, and SOPs. 

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree or equivalent.

 

* Minimum 15 years of experience in Audit Assurance within the medical device industry with 7 years of specific leadership and/or management experience.  

 

* Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as 40% travel should be expected.

 

PREFERRED QUALIFICATIONS:

 

* Ability to work effectively in a fast paced and dynamic environment.

 

* Leadership and interpersonal skills to develop and manage good working relationships with internal departments (R&D, Manufacturing, Supply Chain, Quality etc)

 

* Strong analytical skills, and the ability to analyze and identify trends and root causes

 

* Very strong risk/auditor skills – critical to evaluate remediation of issues and management’s action plans

 

* Significant experience reviewing/providing feedback on audit work performed by others, is highly valued.

 

* Strong written and verbal communication skills.

 

* Regulatory Agency as Compliance Officer preferred.  

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 || 


Nearest Major Market: Worcester

Job Segment: Executive, VP, Quality Manager, QA, Management, Quality

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