Savara Inc. · 2 hours ago
Executive Director, Quality Assurance- Clinical QA & Drug Safety
United States
Full-time
Remote
Director/Executive
$250K/yr - $285K/yr
10+ years expSavara Inc. is a clinical stage biopharmaceutical company focused on rare respiratory diseases. They are seeking an Executive Director of Quality Assurance to provide strategy and direction for Good Laboratory Practices, Good Clinical Practices, and Good Pharmacovigilance Practices, ensuring quality and compliance across clinical development and operations.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Establish and maintain an integrated quality assurance oversight program for GLP, GCP and GVP areas that engrain the GxP requirements and are compliant with Health Authorities and industry standards
Accountable for ensuring data integrity principles are visible and monitored across the GxP areas
Accountable for inspection readiness related to both internal groups and external vendors related to GLP, Clinical Development, Clinical Operations and Pharmacovigilance
Define and implement a strategic plan for maintaining organizational inspection readiness across all GLP, GCP, and PV functions and external vendors
Provide QA leadership and Subject Matter Expertise (SME) for the GCP and GVP teams so that there is alignment on execution of work and compliance standards
Provide updates to our policies, procedures and practices based on quality and regulatory intelligence from Health Authorities, Regulators and Industry. Implement changes using a risk based approach
Implement a risk based approach to PV activities, defining appropriate metrics and trending
Provide leadership and decision-making for GxP issue management, change control and vendor management activities relevant to current and completed clinical trials and GLP studies
Collaborate directly with quality and regulatory stakeholders to ensure quality oversight relevant to health authority submissions and inspections
Lead cross-functional teams, and manage, coach and grow direct reports
Collaborate with stakeholders such as Global Technical Operations and Supply Chain, Clinical Operations, Clinical Development, and Regulatory Affairs, to ensure inspection preparedness, conduct compliance assessments, identify and mitigate compliance gaps, and offer guidance related to GxP processes
Manage team of employees including hiring and onboarding, developing talent, and directing work
Other duties as assigned
Qualification
Required
B.S./M.S./Ph.D. in relevant science field
10+ years of progressive global quality/regulatory compliance background in pharma/biotech, with a hands-on role in quality operations and quality systems
Proven history of supervisory experience
Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations (CFR) related to GLP, GCP and GVP, ICH Guidelines, and Health Authority requirement. Experience with GMP preferred
Experience in the biotech or pharmaceutical industry managing Health Authorities during inspections and managing Customer/Business Partners during inspections is required
Experience with QA oversight of clinical laboratory and GLP activities, including protocol review and reviewing study reports
Demonstrated ability to provide QA oversight of end-to-end GCP activities, including study protocol review, quality event reporting, oversight of sites, CRO and Sponsor activities, trial start up activities, site audits, and related Clinical Operations documents (study reports, TMF, etc.)
Demonstrated ability to provide QA oversight of end-to-end GVP activities, including case processing, safety surveillance and risk management, Serious Adverse Event (SAE) reporting
Provide QA oversight of regulatory submissions and updates related to these areas of GxP as well as periodic safety reports (DSUR, PSUR, etc.)
Working knowledge of the requirements of data integrity to provide training, and integrate across the GxP areas
Excellent verbal and written communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance
Withholds judgment to address conflict in a positive manner by acknowledging dissenting opinions and identifying options to achieve an equitable solution
Models team spirit, culture, and ethics
Develops talent through mentoring and coaching
Demonstrates a high level of independent quality judgment and acumen, comfortable with developing strategy and associated work plans with minimal oversight
Uses broad expertise or unique knowledge and skills to drive and deliver on company core objectives, and achieve goals with measurable impact and outcomes
Preferred
Experience with GMP preferred
GCP Auditor certifications preferred
International/global experience preferred
Benefits
Highly competitive medical, dental, and vision coverage
Flexible Spending Account for health care and dependent care expenses and Health Savings Account
Paid time off and paid holidays, including Dec 24-Jan 1
Paid parental leave
401(k) with highly competitive match
Life, AD&D, STD and LTD insurance coverage
Company
Savara Inc.
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$668.6MKey Investors
RTW InvestmentsHercules CapitalSilicon Valley Bank
2025-10-29Post Ipo Equity· $149.5M
2025-10-29Post Ipo Debt· $75M
2025-03-26Post Ipo Debt· $30M
Leadership Team
Matthew Pauls
Chief Executive Officer
Kate McCabe
Chief Legal Officer
Recent News
Morningstar.com
2026-01-09
2026-01-09
2025-12-17
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