Shire QC & Documentation Lead in Lexington, Massachusetts

Summary:

  • Provides comprehensive review of all types of bioanalytical documentation, such as protocols, SOPs, test methods, data, and reports, including QC and verification of all references and source data, through collaboration with BBD scientists, to achieve the highest quality from technical and compliance perspectives

  • Ensures regular, on-going communication with BBD, Regulatory Submissions, and Compliance colleagues to prioritize review of documentation to meet project timelines

  • Provides project management support and participates in project and portfolio review with the Head of BBD and LT

  • Responsible to maintain and update internal departmental procedural guidances.

  • Responsible for maintaining and tracking internal departmental documents such as memos and method development reports, and for coordinating their final archiving

  • Coordinates submission of all BBD documents (e.g. qualification, validation and sample analysis reports), whether generated internally or by CRO partners, to appropriate functions for financial tracking and archiving

  • Responsible for tracking latest regulatory guidance and white papers regarding all bioanalytical assays and facilitates the implementation of these new requirements within BBD by effective communication and gate-keeping the related SOPs, validation and sample analysis reports and other documentation

  • Devlops training materials for and ensures that all members of BBD understand the design and use of departmental servers and SharePoint sites

  • Partners with BBD Head and the LT to effectively manage the departmental processes and operational execution

Responsibilities (% of time):

25%

Effective communication and gate-keeping of internal department guidance documents. Develop and maintain training program in collaboration with BBD LT members

20%

Review of all regulated study documentation generated by Shire’s BBD group, including test methods, forms, SOPs, protocols, assay results and reports to ensure they are in compliance with applicable GLP, CLIA, GCP, FDA and other global regulatory requirements, as appropriate. Manage group training to mitigate future documentation errors. Develop basic metrics to assess whether errors are reduced over time

20%

Work with the Head of BBD and LT to provide project management support and participate in project and portfolio reviews

15%

Develop and maintain electronic file structures on servers and Sharepoint sites. Communicate the design to BBD group.

10%

Provide proactive leadership to represent the BBD group in alignment of Shire internal Compliance/Quality Assurance Units and serve as BBD group’s primary contact

10%

Assist in writing of regulatory submission documents and key scientific publications; minimal administrative support for Head of BBD

Requirements:

  • Requires BS/MS or higher in a relevant scientific discipline and 5+ years industry experience in the pharmaceutical/biotech industry and/or CRO. At least 3 years QC or QA experience in a regulated laboratory with sound knowledge of relevant regulatory guidelines (e.g., GLP, GCP) addressing bioanalytical and biomarker support for both nonclinical and clinical studies and associated activities. Project management experience preferred. Familiarity with O365 Sharepoint is a plus.

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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.