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Global QARA Compliance Head

Req ID:  2781

Working Location: PENNSYLVANIA, CENTER VALLEY 

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 QARA Compliance Head 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 QARA Compliance Head 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.   

 

Primary Responsibilities

 

The Global QARA Compliance Head 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 Customer Quality goals and business value and plans and directs resources and activities of Customer Quality.

 

* Ensures the functional perspective of quality goals are directly tied to market needs and business goals with an emphasis on agility in execution and driving problem resolution to accelerate the pace of delivering to objectives.

 

* Acts as single quality contact for commercial entities as it relates to the Olympus Global Quality Organization.

 

* Identify and address gaps related to all aspects of product quality (e.g., quality systems, people), including opportunities for continuous ongoing innovation and improvements.

 

*  Assures the absence of significant quality issues and regulatory compliance actions by global government agencies through the design and governance of robust, efficient, and consistent Quality Systems, internal and external audit programs, and inspection readiness programs.

 

* Assures appropriate leadership support to all Competent Authorities including PMDA, FDA, NMPA, etc. as well as Notified Body inspections.

 

* Proactively identifies and alerts organization of quality issues/complaints in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.

 

* Assures all supplier quality systems are consistent with Global Quality standards. · Directs the preparation of the department budgets and maintains operating costs within constraints of those budgets.

 

* Build strong relationships with internal and external leaders across the organization (e.g., RROs, Logistics/Supply/Distribution, Regulatory, ESD and TSD Quality and 3rd Party Distribution) related to quality and compliance plan issues.

 

* Inspire, motivate, and communicate vision to associates, peers, commercial operation and Olympus leadership and build consensus toward adoption of and commitment to appropriate standards for quality in support of Olympus market needs and business goals.

 

* Determine and develop quality and compliance competencies and skills needed for the on-going success of the Regions with an eye towards continual building of competencies to enable the Customer quality and overall business vision.

 

* Participate in industry trade groups and provide Customer Quality point of view to actively influence the development of industry positions that may impact the regulatory compliance environment.

 

* Establish contacts as needed to develop continual input concerning pertinent scientific, legislative and compliance activities affecting the industry.

 

* Retains and manages the development of talent for a complex, global business to support the on-going and progressive business needs including identifying and developing successors for critical positions.

Job Requirements

REQUIRED QUALIFICATIONS

 

Minimum requirements are a BA/BS degree or equivalent.

 

* Minimum of 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.

 

* Regulatory Agency as Compliance Officer preferred. 

 

* Excellent interpersonal and leadership skills with diverse cultural approach. 

 

* A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus.

 

* Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.

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 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) || Pennsylvania (US-PA) || Center Valley || 


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