Director of CMC Quality - Kelly Services : Job Details

#x 9; Develop strategies aligning with regulatory standards for manufacturing high-quality clinical supplies and commercial products. Guide internal teams on compliance requirements through various clinical stages to commercialization. Oversee Quality and Compliance aspects of internal and vendor GMP activities. Lead efforts in developing and implementing Quality programs and policies to ensure regulatory compliance. Collaborate on crafting Standard Operating Procedures for CMC and Quality GMP functions. Assist in conducting CDMO audits and formulating CDMO Quality Agreements. Identify and manage risks related to CMC Quality aspects and devise mitigation strategies. Manage the full spectrum of CMC Quality processes including reviewing manufacturing records, assessing testing, and ensuring material disposition. Promote quality principles and manage electronic Quality Management Systems initiatives. Qualifications Required: Bachelors or Masters degree with 10 years in quality managemen...Director, Quality, Clinical Research, Technology, Staffing, Compliance