Mantell Associates is currently partnered with a leading CDMO based in the US, in their search for a Director of Quality Assurance.
Be thoroughly knowledgeable of Standard Operating Procedures (SOPs), including but not limited to assay and testing procedures, and current Good Manufacturing Practices (cGMPs).
Prepare goals for the group on an annual basis.
Supervise and guide internal audits of various departments/processes.
Oversee and perform QA Document Control activities including processing of change requests, manufacturing records, and other documents.
Write, revise, review SOPs and controlled forms and related documents to ensure best practices and current operations.
Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
Oversee supplier quality program and suppliers.
Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements in accordance with company policy.
BS preferred, in a scientific/technical discipline with experience in a quality leadership position within the biological and/or pharmaceutical industry.
Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.
Experience with writing Deviations, Lab investigations and OOS required
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities
Must be able to assess and utilize software and customized programs to meet QC business needs