Associate Director, Sterile & Microbiology Quality Assurance - Germany
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- 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.
Bachelor degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering or related science discipline.
- 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.
- 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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