Senior Director, Quality Assurance – Drug Product

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🕒 vor 1 Monat

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 €220.000 - €245.000 / Jahr

⏰ Vollzeit

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

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SAVARA

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2018

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Savara ist ein biopharmazeutisches Unternehmen in der klinischen Phase, das sich auf die Entwicklung von Behandlungen für seltene Atemwegserkrankungen konzentriert, insbesondere der Autoimmunerkrankung pulmonale Alveolarproteinose (aPAP). Ihr führender Produktkandidat, MOLBREEVI (Molgramostim-Inhalationslösung), ist ein inhalatives rekombinantes GM-CSF, das sich derzeit in der Phase 3 zur Behandlung von aPAP befindet. Das Unternehmen unterhält klinische Programme, medizinische Angelegenheiten, Patientenressourcen und Aktivitäten zu den Investorenbeziehungen im Zusammenhang mit der Weiterentwicklung dieser Therapie. Savara führt klinische Studien durch, arbeitet mit Forschern und Patientenorganisationen zusammen und stellt Informationen zu Diagnostik, erweitertem Zugang und regulatorischem Status bereit.

Beschreibung

• Oversee the Drug Product (DP), Finished Goods (FG), and Combination Product (CP) review and release processes. • Device oversight and product complaint management. • Identify risks, resolve issues, and escalate matters as necessary to ensure product quality for clinical and commercial. • 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). • 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, artwork, and QP-to-QP agreements. • Accountable for the Product Complaint process, maintaining metrics for clinical and commercial supply. • Reviews and approves manufacturing, testing, labeling/packaging, and other related documents for completeness and acceptability. • Authors and/or revises quality documents as required. • Collaborate with key stakeholders (e.g., Clinical Operations, Regulatory Affairs) on analysis and interpretation of applicable GxP regulations. • Participates in inspection readiness and audits for key vendors.

🎯 Anforderungen

• 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. • Ability 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.

🏖️ Vorteile

• Highly competitive medical, dental, and vision coverage • Flexible Spending Accounts for health care and dependent care expenses • Paid time off and paid holidays, including Dec 24-Jan 1 • Paid parental leave • 401k with highly competitive match • Life, AD&D, STD and LTD insurance coverage