Senior Director, Quality Assurance
Description
Satsuma Pharmaceuticals is a biopharmaceutical company preparing to launch AtzumiTM (dihydroergotamine (DHE) nasal powder), a novel therapeutic product approved in the US for the acute treatment of migraine. AtzumiTM incorporates proprietary advanced powder and device technology (SMART – Simple MucoAdhesive Release Technology™) and is designed to be easy-to-use, easy-to-carry and for quick self-administration.
Position Summary:
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 commercialization in the US. This role will oversee GxP quality activities across manufacturing, supply chain, distribution, quality systems, and vendor management to ensure inspection readiness and ongoing compliance. Furthermore, the Head of Quality Assurance will provide quality leadership for commercial launch readiness, including batch disposition, product release processes, complaint handling, deviations, CAPAs, change control, and product quality reviews. This is a critical leadership role responsible for scaling the quality organization to support the commercialization of Atzumiä (Dihydroergotamine) nasal powder and ensuring the highest standards of safety and efficacy. The successful candidate develops and provides quality strategy, vision, and direction across the organization, implementing company-wide GxP policies and practices and providing input to executive management, with decisions carrying long-term impact on the company's compliance posture and market success.
Key Responsibilities:
Build and maintain a scalable quality management system (QMS) that evolves from clinical-stage to commercial-readiness, ensuring compliance with FDA, ICH, and global GxP standards.
Anticipate factors that could influence the company's quality strategy and market position, providing strategic direction across functional areas to support long-term compliance and business success.
Establish and oversee robust commercial quality processes, including final product release/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 the management of deviations, CAPAs, change controls, and quality investigations, ensuring timely resolution and implementation of effective corrective actions.
Proactively identify compliance risks and advise executive management on regulatory developments that impact company strategy.
Apply persuasive, data-driven communication to influence executive decision-making on quality and regulatory strategy.
Lead the development, implementation, and maintenance of GxP SOPs, policies, and controlled documents across all functional areas.
Establish and manage the company-wide GxP training program for employees and consultants to foster a corporate culture of quality and compliance.
Oversee commercial quality systems, including product complaint handling, adverse event reporting coordination, and annual product quality reviews (APQR).
Partner with executive leadership to cascade company-wide quality policies and practices, ensuring consistent adoption and alignment with organizational goals.
Lead and develop the quality organization through subordinate managers and team members, overseeing the successful execution of company-wide quality initiatives.
Proactively identify, assume, and execute additional responsibilities, initiatives, and special projects as business needs evolve.
Minimum Requirements Education/Experience:
A Bachelor of Science degree in a life science discipline (biology, chemistry, etc.) is required; an advanced degree is preferred.
Demonstrated ability to develop and articulate company-wide quality strategy, vision, and direction, with the ability to anticipate emerging risks and their impact on business success.
10+ years of industry experience in Quality Assurance within the pharmaceutical or biotech sectors, with at least 8 years in a leadership role.
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 with European (EMA) or APAC regulations is highly desirable.
Proven experience developing and implementing company-wide QMS platforms and managing complex quality investigations.
Strong interpersonal and communication skills with a "partnership approach" to working with cross-functional project teams and external partners.
Ability to travel up to 30% (domestic and international) for vendor audits and site visits as required.
Proven experience negotiating and influencing at the executive level, partnering with leadership to align quality strategy with organizational goals.
Benefits and Pay:
The expected salary range for this position is $230,000.00 - $270,000.00 USD. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.
Satsuma Pharmaceuticals is committed to providing its employees with benefit options that are comprehensive, competitive, and that individual employees can tailor to their and their families’ specific needs. Eligible employees are offered Health Insurance, Dental & Vision Insurance, Healthcare & Dependent Care FSA, Employee Assistance Program (EAP), 401(k) Savings Plan, Long-term Incentive Plan, Life Insurance, Accident & Disability Insurance, Telemedicine, Generous Paid Time Off, and Company Holidays.
EEO & Employment Eligibility:
Satsuma Pharmaceuticals is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Satsuma Pharmaceuticals also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.