Director Quality EO

Reporting to the VP Global Quality Assurance, the Director Quality Operations, provides technical and compliance guidance and personnel support to processing facilities within their region and has responsibility for the quality oversight of the Sterigenics’ quality system implementation and execution at Sterigenics facilities.

Domestic and international travel is required up to 30%.

Duties and Responsibilities

• Develop a regional quality strategy to ensure adherence with customer expectations and align with the regional strategy.
• Oversee, motivate, mentor and evaluate Quality Managers, and their employee’s performance and provide input, as appropriate, for QA appraisals to the appropriate General Manager and VP of Operations
• Direct involvement in the Hiring, Firing, and Discipline of all Quality Assurance personnel within their assigned region.
• Monitor activities to ensure compliance with core quality measures.
• Gather, analyze and manage quality related data and participate in site and corporate management reviews.
• Direct responsibility for the Global implementation of the company’s Quality System.
• Partner with OpEx team to be a Sterigenics leader in continuous improvement by learning, utilizing and teaching Operational Excellence tools throughout the regions.
• In conjunction with the OpEx team, ensure there is a dynamic project list, inclusive of quality and compliance projects that drive improvement across sites and the region.
• Going to Gemba and spending time in the sites is required.
• Ensure compliance with global regulatory bodies, including but not limited to FDA, EU GMP, ISO, MHLW/JPAL, USDA and MHRA
• Lead programs to ensure continuous operational quality improvement as measured by quality metrics and reported to appropriate levels of management
• Support facilities during internal and external audits and in response to internal and external audit findings to ensure continual positive outcomes.
• Provide technical support regarding the quality management system to senior staff and facility management
• May represent Sterigenics on national standards groups (AAMI, ASTM) as appropriate
• Ensure active participation by the Quality organization with Operations in establishing best- demonstrated practices, working with customers to resolve problems, and achieving productivity gains wherever possible
• Work with Operations, Sales, Expert Advisory Services/RTS and Engineering to justify and implement capital projects and engineering/process changes as required. The responsibility for a successful project includes meeting applicable regulatory and quality system requirements
• Work with the applicable sales representatives to support the customers’ needs and to resolve issues in a timely manner
• Participate in customer meetings presenting Sterigenics quality processes, projects and results.
• Participate in the development of QA staff with the potential to advance into higher positions
• Develop and improve training programs that include job function, as well as interpersonal skills and personal development training.
• Prepare and understand, as required, budgets and financial plans for the Quality organization.  Meet budget responsibilities in the QA operating plan.
• Partner with Operations to meet or exceed site, region and business fiscal goals.
• Work with customers and facilities in approving quality agreements that maintain compliance and meet customer and facility needs.
• Other items as assigned.

Supervision Given

• The site Quality Assurance Managers report indirectly to the Director Quality Operations.  Partnering with the site General Managers, the Director Quality Operations is responsible to oversee, motivate, mentor and evaluate the QAMs and their employee’s performance. Strong lateral leadership and influencing skills are needed in this position.

Education, Experience, & Skill Required

• Bachelor’s Degree, preferred in a technical discipline
• Ten (10) or more years Quality leadership experience in a regulated environment (pharma / medical device preferred) with a proven track record of success.
• Project management experience required; Sterility Assurance experience preferred.
• Background in process management, oper