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Senior Vice President, Corporate Quality

Req ID:  3988

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 Senior Vice President, Corporate Quality (SVPCQ) will oversee the worldwide quality management systems and related processes. This position will be a member of the Olympus Quality Leadership Team (QLT) and actively participate in regional & business unit senior leadership reviews as needed. Functioning in a matrix management environment managing a department of approximately 150 associates with 6-10 direct reports, the SVPCQ has responsibility for developing and leading the business strategic quality plan in collaboration with the QLT and other regional & business unit senior leaders as needed. The SVPCQ works closely with other strategic business leaders to establish, drive, and achieve Olympus key business objectives. The successful leader will work at a Market, Region, and Olympus level to develop strategies, policies, procedures, monitoring systems and service standards to ensure effective implementation and achievement of the Quality and Compliance Plan, which supports the company’s business units, multiple commercial regions and markets in the selling and distribution of Olympus product. The SVPCQ is responsible for executing a global quality management system, ensuring an effective Quality and Compliance plan and 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 SVPCQ provides strategic decision-making, leadership, planning, and prioritization including agility in effective and efficient use of resources and organizational structure across Olympus to meet business and quality/compliance objectives. Results are achieved through associates who are committed to a culture of regulatory & quality compliance, high quality, continuous improvement, safety, and customer focus. The SVPCQ typically champions or sponsors such activities at a Business Unit, Market, Region, or Olympus level.

 

The SVPCQ, will focus on 4 primary areas that will influence how the functional vision and implementation plans align to the business strategic imperatives and global function mission. 1. Ensure Olympus is compliant to all regulatory requirements and standards worldwide. 2. Improving Efficiency Effectiveness of the Olympus QMS 3. Accelerating Talent Development 4. Driving Functional Excellence The SVPCQ, will provide strategic and customer focused leadership and influence within a global environment and will have a strong technical foundation and aptitude coupled with the ability to be a “collaborative facilitator” and leader championing the overall mission of Corporate Quality. They will define and implement the strategic vision changing to internal and external customer needs from a quality system focus in support of Olympus business goals. They will be responsible for overseeing the identification, structuring, and leading programs designed to improve work processes with focus on efficiency and effectiveness to accelerate the pace of business product deliverables while maintaining global quality standards of excellence for the business for all new and marketed products. Additionally, they will have proven creativity and experience in planning, developing, and executing Quality Systems initiatives to maintain world class Quality Systems standards. To meet these requirements, the successful candidate will be directly responsible for Global Quality leadership.

Job Duties

* Creates and maintains a strategic vision with action plans to implement a companywide QMS that meets all global regulatory regulations and standards.

 

* 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.

 

* 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 and 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., QLT, Logistics/Supply/Distribution, Regulatory, ESD and TSD Quality, R&D and 3rd Party Distribution) related to quality and compliance plan issues.

 

* Inspires, motivates, and communicates the 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 businesses with an eye towards continual building of competencies to enable the corporate quality and overall business vision.

 

* Participate in industry trade groups and provide Corporate 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 in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.

 

* Minimum of 15 years of experience in quality management with at least 5-7 years of senior management experience in an FDA and international regulated environment.

 

* Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the MedTech & IVD industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA.

 

* Knowledge of and experience in pre-market regulations including regulatory and risk management processes.

 

* Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.

 

* 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:

 

*  Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.

 

*  Excellent written and oral communication and organizational, project management skills.

 

* Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.

 

* "Out of box" strategic thinker with strong leadership ability.

 

* As a change agent, motivated to improve organization and not be satisfied with status quo.

 

* Strong intellectual curiosity and pursuit of knowledge. Cultivates new ideas. Comfortable with ambiguity and uncertainty.

 

* Must have good judgment and ability to take prudent risks.

 

* Experienced in all regulatory compliance aspects of the business: pre-market, commercial, post market, and regulatory.

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) || Massachusetts (US-MA) || Westborough || 


Nearest Major Market: Worcester

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