Shire QC & Documentation Lead in Lexington, Massachusetts
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):
Effective communication and gate-keeping of internal department guidance documents. Develop and maintain training program in collaboration with BBD LT members
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
Work with the Head of BBD and LT to provide project management support and participate in project and portfolio reviews
Develop and maintain electronic file structures on servers and Sharepoint sites. Communicate the design to BBD group.
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
Assist in writing of regulatory submission documents and key scientific publications; minimal administrative support for Head of BBD
- 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 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.