The individual will lead the development, implementation, and improvement of internal QC systems for internal teams and external partners. You will proactively manage QC gap analyses and help lead CDMO partnerships on analytical method transfer and phase-appropriate qualification and validation. You will not be siloed, but rather you will be expected to interact across different functional groups and partner collaboratively.
Responsibilities
Lead and manage, in partnership with internal cross-functional teams, QC quality events, such as change controls, deviations, adverse stability trends, OOS/OOT/OOE investigations, root cause analysis, and CAPAs.
Partner with internal and external teams to meet timelines and company objectives, including, Non-clinical Development, Quality Assurance, Regulatory, and CRO/CDMOs.
Proactively manage QC gap analyses and QC SOP authoring and revisions for continuous improvement.
Oversee CDMO for analytical method transfer, phase-appropriate qualification/full validation, reference standard generation and qualification, stability program management and quality control related events.
Support CDMO as a technical SME for drug intermediates, DS and DP QC testing activities, ensuring all activities are completed according to established timelines and quality standards.
Support CDMO with management and communication of stability pulls and ensure stability testing occurs within specified testing windows to establish/extend DS and DP shelf life based on stability data.
Coordinate with internal stakeholders to ensure uninterrupted clinical and commercial supplies.
Oversee CDMO to manage reference standard and critical reagent programs, including qualification/requalification, inventory, and bridging activities.
Partner with CMC technical SMEs, QA and Regulatory to prepare and review QC related sections of IND, IMPD, NDA/MAA and global regulatory submissions.
Provide necessary support information for addressing information requests from regulatory agencies.
Boston, Massachusetts