Senior Director, Quality Assurance (Drug Product)- Remote US

Key Responsibilities

• Assures compliance to cGMPs through review and lot disposition of Drug Product (DP) and Finished Goods (FG).
• Provides appropriate Quality oversight of vendors and contract manufacturing organizations (CMOs) as it relates to lot disposition of DP/FG, identifying and resolving product quality issues and risks.
• Provides support to ensure design control documentation and design change control requirements for combination products are complete and acceptable.
• Provides support, review, and approval of clinical and commercial labeling.
• Provides support, review, and approval of all clinical and commercial artwork.
• Provides support, review, and approval of all QP-to-QP agreements.
• Provides appropriate Quality oversight of the device CMO, identifying and resolving product quality issues and risks.
• Accountable for the Product Complaint process, providing appropriate Quality oversight, resolution and maintaining metrics for both clinical and commercial supply.
• Provides appropriate Quality oversight of distribution quality related to 3PLs (third party logistics) and works together with Supply Chain on product availability.
• Reviews and approves manufacturing, testing, labeling/packaging, and other related documents for completeness and acceptability in a timely manner.
• Authors and/or revises quality documents as required.
• Promotes collaboration with key stakeholders (e.g., Global Technical Operations, Clinical Operations, Clinical Development, Pharmacovigilance, Pharmaceutical Development, Regulatory Affairs) to work together on the analysis and interpretation of applicable GxP regulations.
• Supports the administration of the company’s training program by assisting in the GxP training to internal departments and externally, as applicable.
• Participates in inspection readiness and audits for key vendors, and coordinates responses to Health Authorities as necessary.
• Participates in generating and presenting metrics related to these areas of expertise.
• Participates with the tracking GxP compliance audit trends and group metrics and presenting metrics driven data to upper management.
• Aids in the review of regulatory submissions as necessary for clarity and compliance with current regulations.

Required Skills And Experience

• Demonstrated knowledge and thorough understanding of commercial and clinical manufacturing, artwork and labeling, product complaints, device manufacturing, distribution quality, quality processes, US/EU/ROW Health Authority regulations, and industry standards such as ICH, WHO, and RX360 for the pharmaceutical industry.
• Continually evaluates and interprets regulatory standards and ICH guidelines to provide insight into current processes and recommends updates as appropriate.
• Extensive experience in a virtual manufacturing environment. Biologics technical understanding is required. Small molecule and combination products is preferred.
• Excellent verbal, written, and presentation communication skills, ability to collaborate with cross-functional teams and independently prioritize work, build relationships, and manage multiple projects while maintaining quality and advocating compliance.
• Able to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
• Able to deal with ambiguity, and provide creative and pragmatic solutions to issues and risks.
• Auditor certifications preferred.
• 10+ years of progressive global quality/regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems preferred.
• B.S./B.A. in a related discipline (STEM, pharmacy, medical, etc.) and 12 years of related experience or, M.S. in a related discipline (STEM, pharmacy, medical, etc.) and 10 years of related experience, or Ph.D. degree in a related discipline (STEM, pharmacy, medical, etc.) and 8 years of related experience.

About Savara

Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead product candidate, MOLBREEVI*, is an inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational eFLOW® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. Our goal is to become a leader in rare respiratory disease therapeutics through the development and commercialization of novel, best-in-class medicines that address unmet medical needs in this field. Savara is an equal opportunity employer.