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Astellas Pharma Associate Quality Systems Document Control Manager in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing an Associate Quality Systems Document Control Manager opportunity in Northbrook, IL.

Purpose & Scope:

Responsible for the development and maintenance of the Quality Management System (QMS) Document Control system supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs, and other functions that utilize the Document Control system. Contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.

Essential Job Responsibilities:

  • Functions in support Authors in document development by reviewing new or updated Documents for compliance to Astellas Documents standards.
  • Ensures high quality documentation for all Documents before release and ensures administration of the Quality Document life cycle management is complete and correct.
  • Responsible for ensuring correct stakeholders are identified and involved in reviews of new and revised Documents.
  • Collects metrics on the processing of requests and publication of Quality Documents.
  • Responsible for effective communication of information on new or updated Documents to relevant staff.
  • Responsible for providing Training functions with all relevant information on Documents for training impacted staff.
  • Provide guidance on writing SOPs and other Documents according to Astellas standards.
  • Responsible for responding to inquiries regarding document processing and requirements.
  • Supports the communication and follow up to the respective process owners for the Periodic Review cycles for Documents.
  • Develops and delivers ad-hoc training for system users for effective Document writing using the Astellas Document Management System and standards.

Quantitative Dimensions:

  • Functions as the CRQA contact for all functional areas utilizing the Document Management system globally across Astellas.
  • Supports the CRQA staff of approximately 70 individuals, by offering consultation, advice, and subject matter expertise regarding document control requirements.
  • Supports over 50 Document Authors on proper document development.

Organizational Context:

  • The Associate Quality Systems Document Control and Development Manager reports to the Associate Director, Quality Systems Document Control and Development.

  • No people management responsibilities

Qualifications:

Required:

  • BS/BA Degree (Life Sciences desirable)
  • 0 -2 years working experience in the pharmaceutical industry, 1 of which should be within Quality Assurance and/or within SOP writing or Process Improvement.
  • Excellent SOP writing and communications skills.
  • Demonstrated good training skills.
  • Demonstrated strong interpersonal relationship and influencing skills.
  • Proficiency in Microsoft Office (Word, Excel, Powerpoint, MS Project)

Preferred

  • Broad knowledge of the drug development and maintenance process and GxP.

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Clinical and Research Quality Assurance (CRQA)

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