Provides strategic direction for QC analytical and microbiology testing, environmental monitoring and assay qualification/validation. Develops, implements and maintains the activities of quality control systems. Oversees quality control operations to assure compliance with quality systems, and all applicable regulations. Represents QC in cross-functional CMC teams and is accountable for managing, coordinating, and communication status on all QC related activities such as release/stability testing, LIR investigations, outsourcing activities. Ensures that specifications for raw materials, drug substances, and drug products are phase appropriate and meet cGMP, all other applicable regulations, and ICH guidelines. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• Manages QC personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews, and managing QC budget
• Provides long-term planning for the QC department in alignment Company’s clinical development and commercialization objectives
• Ensures QC testing is scheduled and performed in accordance with project timelines
• Leads the qualification, validation and execution of analytical methods for drug product and drug substance lot release and stability, environmental monitoring and in-process testing.
• Participates in planning and prioritizing daily activities of the QC staff.
• Ensures cGMP compliance in accordance with established test procedures
• Oversees laboratory investigations, including OOS, and QC related deviation investigations
• Works closely with Analytical Development team to transfer new or optimize existing assays and establish specifications
• Develops and manages to QC Metrics
• Routinely collaborates with the management team to develop and improve laboratory systems and procedures, revise Test Procedures SOPs, and summarize present data.
• 10+ years of experience in the pharmaceutical or biotechnology industry with at least 7 of those years in QC management
• The position requires experience with GLP/GMP analytical testing requirements and guidances and the ability to troubleshoot assay performance.
• Experience with data analysis software and LIMS is a plus.
• Experience with physico-chemical testing methods
• Experience with biological test methods
• Experience with environmental monitoring procedures and testing
• Experience with coordinating quality control related activities with company strategic vision and quality assurance.
• BS or MS in Biological Sciences, experience with cell-based, biochemical and or immunochemical methodology
Preferred Additional Skills (i.e., Computer):
• Proven strong interpersonal, organizational and problem-solving skills
• Solid and demonstrable knowledge and understanding of US and international (e.g. EU, ICH) GXP regulations, procedures and guidelines applicable to Quality Control
• Excellent organizational skills and the ability to work on multiple projects with varying complexity and timelines
• Effective verbal and written communication skills, detail-oriented with the ability to work effectively in a fast paced, multi-disciplinary team environment