Senior Director, Quality Assurance

Satsuma Pharmaceuticals

13d•$230,000 - $270,000

About The Position

Satsuma Pharmaceuticals is seeking an experienced, strategic leader to serve as Head of Quality Assurance. This individual will lead quality strategy and quality management systems through launch and early US commercialization of Atzumi (dihydroergotamine nasal powder), a product approved in the US for the acute treatment of migraine. The role oversees GxP quality activities across manufacturing, supply chain, distribution, quality systems, and vendor management, ensuring inspection readiness and ongoing compliance. The Head of Quality Assurance will provide leadership for commercial launch readiness, including batch disposition, product release processes, complaint handling, deviations, CAPAs, change control, and product quality reviews. The role is responsible for scaling the quality organization and maintaining high standards of safety and efficacy. It develops and provides quality strategy, vision, and direction across the organization; implements company-wide GxP policies and practices; and provides input to executive management on decisions with long-term effects on compliance and market success.

Requirements

Bachelor of Science degree in a life science discipline, such as biology or chemistry.
At least 10 years of Quality Assurance industry experience in the pharmaceutical or biotech sectors.
At least 8 years in a leadership role.
Demonstrated ability to develop and articulate company-wide quality strategy, vision, and direction, and anticipate emerging risks and their effect on business success.
Demonstrated success leading a quality function through a US commercial product launch and transitioning from clinical to commercial GxP requirements.
Expert knowledge of US FDA GxP and ICH requirements.
Experience developing and implementing company-wide QMS platforms and managing complex quality investigations.
Strong interpersonal and communication skills and a partnership approach to working with cross-functional teams and external partners.
Ability to travel up to 30% domestically and internationally for vendor audits and site visits as required.
Experience negotiating and influencing at the executive level and partnering with leadership to align quality strategy with organizational goals.

Nice To Haves

An advanced degree.
Experience with European (EMA) or APAC regulations.

Responsibilities

Build and maintain a scalable quality management system that evolves from clinical-stage to commercial readiness and complies with FDA, ICH, and global GxP standards.
Anticipate factors that could influence quality strategy and market position, and provide strategic direction across functional areas.
Establish and oversee commercial quality processes, including final product release and disposition, supply chain security, and distribution quality.
Provide quality oversight for GLP, GCP, and GMP vendors; lead vendor qualifications, perform audits, and manage quality agreements with contract manufacturing and research organizations.
Lead deviations, CAPAs, change controls, and quality investigations, ensuring timely resolution and effective corrective actions.
Identify compliance risks and advise executive management about regulatory developments that may affect company strategy.
Communicate persuasively and using data to influence executive decisions on quality and regulatory strategy.
Lead development, implementation, and maintenance of GxP SOPs, policies, and controlled documents across functional areas.
Establish and manage a company-wide GxP training program for employees and consultants.
Oversee commercial quality systems, including product complaint handling, adverse event reporting coordination, and annual product quality reviews.
Partner with executive leadership to cascade company-wide quality policies and practices and promote consistent adoption and alignment with organizational goals.
Lead and develop the quality organization through subordinate managers and team members, overseeing company-wide quality initiatives.
Take on and execute additional responsibilities, initiatives, and special projects as business needs evolve.