Senior Director, Quality Assurance

Satsuma Pharmaceuticals, Inc.

. Lead quality strategy and quality management systems through launch and early commercialization in the US .

Posted 11/7/2026full-timeRemote • United StatesSenior💰 $230,000 - $270,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading quality management systems and ensuring compliance with FDA, ICH, and global GxP standards. Proven ability to develop quality strategies and oversee commercial launch readiness while managing vendor qualifications and quality investigations.

Highest-signal resume keywords

Quality Assurance LeadershipGxP Compliance ExpertiseQuality Management System DevelopmentRegulatory Strategy InfluenceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Strategy DevelopmentGxP SOP ImplementationQuality Investigations ManagementBatch Disposition OversightCAPA ManagementChange Control ProcessesProduct Release ProcessesVendor AuditingComplaint HandlingRegulatory Compliance

Soft Skills

Interpersonal SkillsCommunication SkillsNegotiation SkillsLeadership SkillsTeam Development

Industry Keywords

PharmaceuticalBiotechFDA RegulationsICH GuidelinesGMPGLPGCPEMA RegulationsAPAC RegulationsQuality Management Systems

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead quality strategy and quality management systems through launch and early commercialization in the US
Oversee GxP quality activities across manufacturing, supply chain, distribution, quality systems, and vendor management
Ensure inspection readiness and ongoing compliance
Provide quality leadership for commercial launch readiness
Oversee batch disposition, product release processes, complaint handling, deviations, CAPAs, change control, and product quality reviews
Build and maintain a scalable quality management system evolving from clinical-stage to commercial-readiness
Ensure compliance with FDA, ICH, and global GxP standards
Establish and oversee 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 deviations, CAPAs, change controls, and quality investigations
Identify compliance risks and advise executive management on regulatory developments
Influence executive decision-making on quality and regulatory strategy through data-driven communication
Develop, implement, and maintain GxP SOPs, policies, and controlled documents
Establish and manage the company-wide GxP training program
Oversee product complaint handling, adverse event reporting coordination, and annual product quality reviews (APQR)
Partner with executive leadership to implement company-wide quality policies and practices
Lead and develop the quality organization through subordinate managers and team members
Execute additional responsibilities, initiatives, and special projects as business needs evolve

Requirements

What you’ll need

A Bachelor of Science degree in a life science discipline (biology, chemistry, etc.) is required; an advanced degree is preferred
10+ years of industry experience in Quality Assurance within 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
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
Ability to align quality strategy with organizational goals

Benefits

Comp & perks

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
Company Holidays