Site Quality Head

Site Quality Head About the Company Clinical-stage manufacturing organization supporting sterile drug product programs IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a Site Quality Head to lead Quality Assurance, Quality Control, Quality Systems, and Compliance activities at a regulated manufacturing site. The role is responsible for establishing and maintaining a site quality system aligned with regulatory requirements and global standards, while overseeing quality across manufacturing from material dispensing through final product release. Key duties include directing quality strategy, audits, compliance programs, and continuous improvement; overseeing laboratories, environmental monitoring, and stability testing; and guiding investigations, deviations, and quality decisions. The Site Quality Head will also lead and develop quality teams, serve as the primary quality contact for customers and regulators, manage the site quality budget, and foster a culture of accountability and collaboration. Candidates must hold a bachelor’s degree in a relevant scientific discipline and have at least 15 years of progressive quality operations experience in a regulated environment, including project, technical, and personnel management. At least five years of experience leading cross-functional quality teams is required, along with expertise across quality assurance, compliance, quality control, quality systems, and continuous improvement. Direct experience in aseptic drug product manufacturing, including lyophilized and liquid fill-finish processes, and strong GMP laboratory leadership across analytical and microbiology functions are essential. The ideal candidate also brings experience with client-facing quality oversight, audit responses, investigations, and technical problem-solving, along with excellent communication skills and sound, timely compliance-focused judgment. Functions Operations