Director of Quality, San Jose Operations

Job Description

The Director of Quality, San Jose Operations is responsible for GMP Operations of the facility inclusive of manufacturing quality, repair quality, distribution quality, quality inspection and quality systems. This role will ensure quality systems and processes are established, maintained, and continuously improved to consistently deliver right first-time quality, safeguard patient safety, and ensure customer satisfaction. The Director of Quality will ensure that sethe site is inspection ready at all times, manage and facilitate site audits and inspections, lead execution of commitments to regulators, and ensure that quality and/or compliance issues are corrected in a timely manner. This role will lead site initiatives aimed at building and sustaining a strong culture of quality and will work collaboratively with other functions at the site to achieve quality and business objectives. This position serves as the default Quality Management Representative for the San Jose site.  This position reports into the Quality organization directly and also reports indirectly to Top Management at the San Jose site.

Job Duties

• Leadership of the Site Quality organization and serves as site quality management representative
• ensuring efficient and flawless execution of quality systems and processes to ensure product quality and compliance with global and site policies and procedures, FDA regulations, and other applicable regulations, standards and guidance.
• In accordance with established budget, builds organizational capability and capacity to meet both the current and future needs of the business through talent acquisition, employee training / development and performance management.
• Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that projects are appropriately prioritized in alignment with regulatory requirements and business goals.
• Hosts external regulatory inspections and audits and ensures successful outcomes through inspection readiness activities, inspection management and observations resolution.
• Promotes awareness of regulatory requirements and expectations and ensures understanding of quality system requirements across the site. Identifies site training needs and leads efforts to ensure effective training delivery.
• In accordance with quality system and technical requirements and risk management documents, ensures implementation of effective process controls for manufacturing, servicing and supply chain operations that support timely delivery of products that consistently conform to their specifications. This includes validation and maintenance of the Site Master Validation Plan, calibration, equipment maintenance, critical component evaluations, and quality inspections.
• Anticipates and identifies quality and compliance risks and proactively collaborates with Operations and Supply Chain leaders to identify potential areas of process and product variability.
• Implements controls to prevent escape of nonconforming product, drives timely and thorough root cause investigations for quality issues (e.g., NCs, customer complaints), and ensures implementation of effective corrective and preventive actions (CAPA) to mitigate recurrence of quality problems. Acts with appropriate levels of urgency commensurate with risk and escalates issues to management.
• Lead complex investigations to identify causes of problems to safeguard patient safety and business continuity.
• Utilizes data to assess the overall health and effectiveness of the site’s quality system and processes and identifies areas to improve efficiency and effectiveness.
• Maintains budgetary oversight for the Site Quality Operations organization. Partners with Finance and Operations business partners to ensure that expenses, headcount and capital are in alignment with business goals, financial targets and strategic plans.
• Partners closely with the site leadership team to prioritize programs to reduce product failures and ensures timely execution of initiatives.
• Engage in a positive manner with team members from all disciplines to enhance the culture of quality and maintain a patient and customer focused quality mindset.
• Other duties as assigned.

Job Qualifications

Required:

• Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science.
• A minimum of 10 years of cGMP experience in quality management (with direct shop floor experience) within the MedTech industry.
• Experience with durable medical devices, and a strong understanding of repair operations and servicing requirements to ensure they continue to meet safety and performance specifications over their usable life.
• Demonstrated experience influencing senior level management and key stakeholders and leveraging cross-functional partnerships for successful execution of critical quality initiatives.
• Experience interpreting and applying business requirements and regulations (FDA and other applicable global authorities) into sustainable quality processes leveraging industry best practices.
• Will work with global teams, availability will include working across global time zones. 

Preferred:

• Advanced technical degree and/or MBA preferred.
• Lean Six Sigma Black Belt Certification desired.
• Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.
• Strong ability to think and act globally, be fearless change agent while managing risks, develop future visions and engage audiences to drive transformation.
• Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.
• Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.
• Must be a self-starter with high personal accountability and courage to always do the right thing.
• Driving cultural change in a complex and diverse Olympus organization.