Job Description

The Senior Vice President, Product, Design and Supplier Quality Management – (SVPQM) will oversee the global Product, Design Assurance and Supplier Quality leaders’ organization across all manufacturing sites, design centers and headquarters facilities assigned to the business units. This position will also be a member of the ExCom, 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 1200 associates with 5-7 direct reports, the SVPQM has responsibility for leading the business strategic quality plan in collaboration with the worldwide Business and Supplier Leadership Teams and Corporate Quality Management, as well as development and execution of the Quality and Compliance business goals. All Quality associates in Manufacturing QA and R&D QA for ESD, TSD and Suppliers 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 ESD and TDS customers. The SVPQM serves as the TSD and ESD division’s senior Quality and Compliance liaison between the company, worldwide competent authorities such as the FDA, PMDA, NMPA, Notified Bodies, other government agencies and customers, and is designated as the person responsible for regulatory compliance (PRRC). 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 SVPQM typically champions or sponsors such activities at a site, division, or Olympus level.

Job Duties

• Thinks “Out of the Box” to optimize business Quality goals and business value and plans and directs resources and activities of the Business and Supplier 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., ESD & TSD Business Heads, ESD & TSD Leaders of Operations, Regulatory and R&D) related to quality and compliance plan issues.
• Inspire, motivate, and communicate vision to associates, peers, ESD, TSD, Supplier, and Olympus leadership and build consensus toward adoption of and commitment to appropriate standards for quality in support of ESD & TSD market needs and business goals.
• Determine and develop quality and compliance competencies and skills needed for the on-going success of ESD, TSD and supplier quality with an eye towards continual building of competencies to enable the business and supplier quality and overall business vision.
• Participate in industry trade groups and provide business 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.
• 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.
• Function as the person responsible for regulatory compliance (PRRC) as defined in the OSTA Quality Manual.

Job Requirements

Required:

• BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
• Minimum of 15 to 20 years of experience in quality management with at least 5-7 years of senior management experience in a worldwide position that is in a regulated environment in the MedTech industry.
• 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.
• Experienced in all regulatory compliance aspects of the business: pre-market, commercial, post market, and regulatory.
• 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:

• 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.

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