Senior Manager/Associate Director, Quality Control

Qualification

An undergraduate degree in life sciences, with 5+ years (Senior Manager level) or 8+ years (Associate Director level) of relevant management experience in the pharmaceutical industry (small molecules and/or biologics). Previous experience working with external testing laboratories; independently and influences in a fast-paced environment, while exhibiting a strong quality mindset. Comfortable working across locations and time zones. Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness is preferred. Strong experience with quality control testing, stability program management in accordance with ICH guidelines, master specifications, method validations, investigations (OOS/OOT), batch release processes, and quality management systems are required. Prior experience with IND, NDA and/or CTA CMC submissions is preferred; knowledge of cGMP and the US, Canadian, and EU regulatory environments. Collaboration and inclusion between external testing labs and cross-functional CMC teams are essential. Excellent oral and written communication skills and previous team leadership experience. Willingness to travel up to 20% of the time domestically and internation