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Director RA/QA EMEAA

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.

    • Anderen bekeken ook

    Director RA/QA EMEAA

    Bedrijf:
    Sotera Health
    Gemeente:
    Leuven
    Contracttype: 
    Vast contract
    Categorieën: 
    Quality Assurance Engineer
    Opleidingsniveau: 
    Bachelor
    Carriereniveau: 
    Director
    Gepubliceerd:
    03.05.2024
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