Quality Affairs Sr Director

Job description

Nature and Scope: Reporting directly to the Vice President of Quality Affairs, the Quality Affairs Sr. Director serves as a key strategic leader with comprehensive responsibility for setting and driving the highest standards of quality across all phases of production and testing of small molecule sterile injectable and lyophilized products, cytotoxic large molecule sterile injectable and lyophilized products, pre-filled syringes (PFS) and combination products. This role is accountable for establishing and maintaining rigorous compliance with all regulatory requirements and quality systems, ensuring excellence in laboratory operations, documentation, and management of Regulatory Body Inspections (e.g., FDA, EMEA, Health Canada, etc.). The Quality Affairs Sr. Director will champion strategic quality initiatives, spearhead continuous improvement processes, and cultivate a culture of quality throughout the organization. This position is expected to demonstrate strong leadership and influence at all organizational levels, both domestically and internationally, serving as a visible role model for operational excellence and compliance. Essential Duties and Responsibilities: Nothing in thi...