POSITION SUMMARY:
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.
DUTIES AND RESPONSIBILITIES:
Ensure compliance with global regulatory bodies, including but not limited to FDA, ISO, MHLW/JPAL, USDA and MHRA.
Track and understand all applicable Quality and Regulatory regulations that impact Sterigenics operations in our Europe and Asia facilities.
Work with local regulatory agencies on new and existing permits, licenses and regulations that impact our operations.
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.
Lead programs to ensure continuous operational quality improvement as measured by quality metrics and reported to the appropriate levels of management.
Support facilities during internal and external audits and in response to internal and external audit findings.
Participate in annual Management Review and monthly data analysis meetings.
Provide technical support regarding the quality management system to senior staff and facility management.
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.
Represent Sterigenics on international standards groups as appropriate.
Ensure active participation by the Quality organization with Operations in establishing best- demonstrated practices.
Work with customers to resolve problems and achieving productivity gains wherever possible.
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.
Work with the applicable sales representatives to support the customers’ needs and to resolve issues in a timely manner.
Work with the cross-functional EMEAA Regional Leadership team to define and execute short- & long-term improvement initiatives linked to company strategy
Participate in customer meetings presenting Sterigenics quality processes, projects and results.
Participate in the hiring and training 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.
Provide input for Quality Manager appraisals to the appropriate General Manager or VP of Operations.
Provide input for all disciplinary actions taken on all regional QA employees.
Prepare and understand, as required, budgets and financial plans for the Quality organization. Meet budget responsibilities in QA operating plan.
Work with Operations to meet or exceed the fiscal goals of the organization.
SUPERVISION GIVEN:
Directly Supervised by the Global VP Of Quality Assurance and Regulatory Affairs. Indirectly reports to the Regional VP of Operations.
The Director of Quality Assurance and Regulatory Affairs – EMEAA has indirect responsibility for the QA Managers within the EMEAA facilities.
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
EDUCATION, EXPERIENCE & SKILL REQUIRED:
Bachelor’s Degree or 8 years of experience in quality / sterilization (or related field).
Qualified Person (QP) is preferred.
Relevant experience in management function (minimum 3 years).
Proficiency in the pharmaceutical / medical device industry is preferred.
Proficiency in auditing and being audited.
Proficiency in CAPA performance.
Experience with Quality Systems and applying Regulatory Standards.
Experience with ISO, European EU, and FDA regulations.
Must be able to read, write and speak English. Additional European language proficiency (French, German, Italian) would be preferred.
Excellent organizational skills.
Excellent communication skills on all levels.
Efficient, accurate, works according to plan.
Flexible.
Problem-solving attitude.
High profile commitment to quality.
SPECIAL REQUIREMENTS:
Requires travel up to 30%.
Some international travel is expected.
TRAINING REQUIRED:
Must complete all required training for a “Quality Assurance Director” outlined in the training program.
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics . LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.
VEVRAA Federal Contractor
