The Associate Director, EQO is responsible for leading a department the External Quality Operations (EQO) group, primarily focused on biologics and parenterals. The group has quality oversight of active pharmaceutical ingredients (APIs) and Bulk Drug Substances (BDS) and finished drug products (FDPs) manufactured by external manufacturing organizations (EMOs) for commercial and clinical distribution. He/she coordinates EQO resources so that all external product teams’ business needs are met on schedule. He/she is responsible for ensuring consistent and rational application of quality policies amongst the external product teams. He/she is highly independent given his/her extensive GMP, scientific and technical knowledge, and job-related experience and leads a group managed in a matrix environment. He/she ensures effective teamwork by developing strong relationships with direct reports, internal/external customers, peers, and management, and through highly effective (oral and written) communication skills. He/she reports directly to Senior Director, Americas Region Quality.
Responsible for developing, recommending and managing quality project plans, vendor quotes, timelines and budgets for projects up to $100K w/o supervisory oversight and pre-approved project budgets up to $500K with limited supervisory oversight. May manage CMO capital projects depending on the nature of the investment.
The Associate Director, EQO is directly responsible and accountable for ensuring that the following key activities are executed according to the agreed schedule(s) for all external products:
He/she is also expected to continuously assess internal Quality systems for their applicability in managing EMO compliance.
He/she must expect to travel approximately 10% of time (domestic and international).
Desirable But Not Essential
Serve as an SME for areas of responsibility during regulatory inspections