Director RA/QA EMEAA

<p> </p> <p><strong>POSITION SUMMARY:</strong></p> <p>Reporting to the VP Global QA, the Director of Quality Assurance and Regulatory Affairs – EMEAA, provides technical, compliance, and regulatory guidance to processing facilities within Europe and Asia and has responsibility for the quality oversight of Sterigenics’ quality system implementation and execution.</p> <p><strong>DUTIES AND RESPONSIBILITIES:</strong></p> <ul> <li>Ensure compliance with global regulatory bodies, including but not limited to FDA, ISO, MHLW/JPAL, USDA and MHRA.</li> <li>Track and understand all applicable Quality and Regulatory regulations that impact Sterigenics operations in our Europe and Asia facilities.</li> <li>Work with local regulatory agencies on new and existing permits, licenses and regulations that impact our operations.</li> <li>Review and certify pharmaceutical product sterilization process runs and procedures as an Industrial Pharmacist.  Ensure ongoing compliance with pharmaceutical Manufacturing Authorizations in relation with Competent Authorities.</li> <li>Lead programs to ensure continuous operational quality improvement as measured by quality metrics and reported to the appropriate levels of management.</li> <li>Support facilities during internal and external audits and in response to internal and external audit findings.</li> <li>Participate in annual Management Review and monthly data analysis meetings.</li> <li>Provide technical support regarding the quality management system to senior staff and facility management.</li> <li>Ensure the consistent application and maintenance of the Quality Management System across the EMEAA facilities. Participate or lead the development, review, and approval of appropriate levels of the system.</li> <li>Represent Sterigenics on international standards groups as appropriate.</li> <li>Ensure active participation by the Quality organization with Operations in establishing best- demonstrated practices. </li> <li>Work with customers to resolve problems and achieving productivity gains wherever possible.</li> <li>Work with Operations, Sales 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.</li> <li>Work with the applicable sales representatives to support the customers’ needs and to resolve issues in a timely manner.</li> <li>Work with the cross-functional EMEAA Regional Leadership team to define and execute short- &amp; long-term improvement initiatives linked to company strategy</li> <li>Participate in customer meetings presenting Sterigenics quality processes, projects and results.</li> <li>Participate in the hiring and training of QA staff with the potential to advance into higher positions.</li> <li>Develop and improve training programs that include job function, as well as interpersonal skills and personal development training.</li> <li>Provide input for Quality Manager appraisals to the appropriate General Manager or VP of Operations.</li> <li>Provide input for all disciplinary actions taken on all regional QA employees.</li> <li>Prepare and understand, as required, budgets and financial plans for the Quality organization.  Meet budget responsibilities in QA operating plan.</li> <li>Work with Operations to meet or exceed the fiscal goals of the organization.</li> </ul> <p> </p> <p><strong>SUPERVISION GIVEN:</strong></p> <ul> <li>Directly Supervised by the Global VP Of Quality Assurance and Regulatory Affairs. Indirectly reports to the Regional VP of Operations.</li> <li>The Director of Quality Assurance and Regulatory Affairs – EMEAA has indirect responsibility for the QA Managers within the EMEAA facilities.</li> <li>The Director of Quality Assurance and Regulatory Affairs – EMEAA is a permanent member of both the Global Quality Leadership Team and the cross-functional EMEAA Regional Leadership Team</li> </ul> <p><strong>EDUCATION, EXPERIENCE &amp; SKILL REQUIRED:</strong></p> <ul> <li>Bachelor’s Degree or 8 years of experience in quality / sterilization (or related field).</li> <li>Qualified Person (QP) is preferred.</li> <li>Relevant experience in management function (minimum 3 years).</li> <li>Proficiency in the pharmaceutical / medical device industry is preferred.</li> <li>Proficiency in auditing and being audited.</li> <li>Proficiency in CAPA performance.</li> <li>Experience with Quality Systems and applying Regulatory Standards.</li> <li>Experience with ISO, European EU, and FDA regulations.</li> <li>Must be able to read, write and speak English. Additional European language proficiency (French, German, Italian) would be preferred.</li> <li>Excellent organizational skills.</li> <li>Excellent communication skills on all levels.</li> <li>Efficient, accurate, works according to plan.</li> <li>Flexible.</li> <li>Problem-solving attitude.</li> <li>High profile commitment to quality.</li> </ul> <p> </p>