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Associate Director, Sterile & Microbiology Quality Assurance - Germany  

Company managed [?] Still accepting applications

Posted on : 22 April 2017

Project Description


Description
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where company has codified its 125-year legacy.
  • Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
  • Associate Director, Sterile and Microbiology Quality Assurance, is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic Manufacturing, and/or Microbiology Laboratories in for assigned topics. Leads the development, deployment and maintenance of multiple divisional quality standards or SOP to ensure MMD is compliant to cGMPs for these topics.
  •  Serves as the Sterile and Microbiology QA point of contact for multiple sites in the MMD network. 



As the Sterile and Microbiology QA lead for specific topics, is responsible for:
  • Identifying the regulatory requirements and cGMP expectations.
  •  Developing, authoring, and maintaining the divisional quality standards in alignment with regulatory requirements and cGMP expectations.
  •  Developing change control package for divisional microbiology analytical standards
  •  Deploying and ensuring consistency in sites meeting the standards for the topic (e.g. providing training, supporting gap assessments, reviewing remediation plans and variances).
  •  Tracking metrics for MMD network sites to meet the divisional standards, where applicable.
  •  Defining and tracking quality metrics to transform performance at MMD network sites, where applicable.
  •  Providing support to CMC when questions arise from regulators during review of filings.
  •  Organizing and facilitating compliance related communities of practice
  •  Representing our company  in external forums, conferences, and working groups such as ISPE, PDA, PhRMA, or USP.



As the Sterile and Microbiology point of contact for a manufacturing area or microbiology lab, is responsible for :
  •  Understanding the compliance gaps and quality improvement goals for microbiology topics.
  •  Coordinating global microbiology team support for prioritized topics.
  •  Working with the sites and regional Quality organizations to ensure consistency and alignment to microbiology topics.
  •  Provides expert support to sites related regulatory inspections, development of responses to inspection observations, significant investigations, and guidance regarding corrective actions.
  •  Co-ordinate regional input into draft policies, procedures and guidelines. Author and/or review technical reports/position papers.


Qualifications
Education:
Bachelor degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering or related science discipline.


Required:
  •  Minimum 10 years experience in sterile pharmaceutical industry.
  •  Experience with EU and/or FDA regulations.
  •  Broad experienced in microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods.
  •  Experience in transforming GMP compliance.
  •  Excellent spoken and written English.
  •  Demonstrated ability to effectively work hands-on with shop floor personnel.
  •  Ability to travel 30 to 50% of the time.



Preferred:
  •  Advanced degree desirable.
  •  Expert knowledge of three or more microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods
  •  Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies that may include US FDA, EMEA, TGA, HPB, ANVISA, COFEPRIS, ANMAT, KFDA and PMDA.
  • Knowledge of USP and EU compendia and ISO industry standards.
  •  Good teacher
  •  Quality Risk Management



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