Senior Contract Development identify improvement opportunities for site performance.
Coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT) Oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team Facilitation of cross-functional teams (internal and external to External Supply).
Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions.
Participate in the assessment or implementation of continuous improvement projects or initiatives.
Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.
Education and Experience: Bachelor's Degree (L8) in Business Administration, Engineering or Science-related field 5 years of experience in GMP protein, API, DS, DP or packaging manufacturing environment Experience in roles requiring knowledge of cGMP principles, FDA and other regulatory agency guidelines, and validation principles Understanding of applicable manufacturing/testing processes (i.e. protein, API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Experience with supporting/managing Third Party CDMO sites Demonstrated experience with QMS