Global QARA Compliance Head
Company: Olympus Corporation of the Americas
Location: Center Valley
Posted on: November 19, 2021
Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA,
BROOKLYN PARK; Nationwide; 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
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
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
1. Global Audit Planning for Internal and External Audit
2. Review and Approve all Official Audit Responses to External
3. Improving Efficiency in Audit Execution and Reporting to
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
* Assures appropriate leadership support to all Competent
Authorities including PMDA, FDA, NMPA, etc. as well as Notified
* 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
* 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
* 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
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
* 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.
* Ability to work effectively in a fast paced and dynamic
* 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
* 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
* Focused, target driven with a positive, can-do attitude and a
desire to improve patient experience as well as company
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
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
Posting Notes: -- United States (US) -- Pennsylvania (US-PA) --
Center Valley --
Keywords: Olympus Corporation of the Americas, Bethlehem , Global QARA Compliance Head, Accounting, Auditing , Center Valley, Pennsylvania
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