||Assoc. Director Quality Control
• Responsible for the daily operations of the QC group, including raw material, in process and finished product testing, stability studies and environmental monitoring. Ensure cGMP compliance in the laboratory, as well as lab safety. Provide leadership to subordinates
and colleagues to resolve technical and operational issues in order to meet deadlines
• Review and approve test data, qualification/validation/verification protocols, data and reports. Monitor and trend QC data.
• Recognize, record and investigate unexpected laboratory developments (e.g. OOS, OOT, OOE) in a timely manner
• Develop, coordinate and maintain compliant cGMP stability operations, in accordance with regulatory guidelines, internal SOPs and industry practices. Write, review and issue stability reports. Draft and review CMC stability sections for regulatory filings.
• Conduct lab investigations and participate in the development and implementation of corrective actions and improvements. Participate in regulatory inspections
• Provide leadership and technical expertise to project teams, team meetings and specification meetings
• Highly organized, detail-oriented, capable of multi-tasking, strong interpersonal skills in order to collaborate with individuals in a matrix environment
• Solid understanding of QC CMC requirements for regulatory filings, including a thorough understanding of regulatory agency stability guidelines and requirements, and current practices.
• Strong knowledge of QC testing of small molecule drugs in a compliant cGMP setting
• Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL, etc.
• Familiarity with LIMS systems
Education and Experience Minimum Requirements: Bachelor’s Degree in science or related field. 10+ years of relevant experience in a cGMP pharmaceutical QC environment, or 8+ years with a Master’s degree. A minimum of 6 years in a supervisory role.