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Senior Vice President, Quality Management TSD

Req ID:  2878

Working Location: PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK 

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, Quality Management (SVPQM) will oversee the worldwide Therapeutic Solutions Division’s (TSD) Quality organization across 9 manufacturing sites, 6 design centers and headquarters facilities assigned to the TSD business unit.  This position will also be a member of the TSD ExCom, TSD Strategic Review Board (SRB), Leadership Alignment Meeting LAM, and the Olympus Quality Leadership Team (QLT). Functioning in a matrix management environment managing a department of approximately 490 associates with 8-10 direct reports, the SVPQM has responsibility for leading the business strategic quality plan in collaboration with the global TSD Leadership Team and Corporate Quality Management, as well as development and execution of the Quality and Compliance business goals for TSD. All Quality associates in both Manufacturing QA and R&D QA for TSD will report into this position.

 

The SVPQM works closely with other strategic business, Manufacturing, and R&D leaders to establish, drive, and achieve divisional/company key business objectives. The successful leader will work at a site, division, 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 multiple design centers and manufacturing sites that produce clinical and research products and services for TSD customers.  

 

The SVPQM is responsible for 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 GVPQM serves as the TSD division’s senior Quality and Compliance liaison between the company, worldwide government agencies such as the FDA, PMDA, NMPA, Notified Bodies, and other government agencies and customers.  

 

The SVPQM provides strategic decision making, leadership, planning and prioritization including agility in effective and efficient use of resources and organizational structure across the division to meet business and quality/compliance objectives.  Results are achieved through associates who are committed to a culture of regulatory compliance, high quality, continuous improvement, safety, and customer focus.  The GVPQM typically champions or sponsors such activities at a site, division, or Olympus level. 

Job Duties

* Thinks “Out of the Box” to optimize ESD Quality goals and business value and plans and directs resources and activities of TSD 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.

 

* 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., TSD Business Heads, TSD Leaders of Operations, Regulatory and R&D) related to quality and compliance plan issues.

 

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

 

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

 

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

 

* 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.

 

* The individual in this role is responsible for creating and sustaining the culture of customer focused innovation, efficiency, and balanced risk management.

 

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

Job Requirements

REQUIRED QUALIFICATIONS
Bachelor's degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree; Master's degree preferred.  

 

* Minimum of 15 to 20 years of experience in quality management with at least 5-7 years of senior management experience in a global  position that is in a regulated environment in the MedTech industry.

 

* Other Considerations (travel/hours availability, etc.): Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as 50 to 70%  travel should be expected.

 

PREFERRED QUALIFICATIONS

Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the 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.


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


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