Senior Director, Quality Assurance

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $230k - $270k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 20%

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Satsuma Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2016

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Satsuma Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing therapies for migraine using its SMART (Simple MucoAdhesive Release Technology) drug-delivery platform. Its first approved product, Atzumi™ (STS101), is a dihydroergotamine (DHE) nasal powder indicated for the acute treatment of migraine with or without aura in adults. The company highlights clinical publications and presentations and emphasizes improved efficacy and administration via its mucoadhesive nasal delivery approach.

📋 Description

• 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

• 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

• 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

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