Senior Pharmaceutical Quality Account Manager

Job not on LinkedIn

🔥 13 minutes ago

🌵 Arizona, Colorado, +12 more states – Remote

🌵 Arizona – Remote ⛰️ Colorado – Remote 🐊 Florida – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote 🧀 Wisconsin – Remote

⏰ Full Time

🟠 Senior

💰 Account Manager

👻 Ghost score 13%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 104 days.
• No salary listed.

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Padagis LLC

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Padagis LLC is a pharmaceutical manufacturer focused on expanding access to high-quality, affordable topical and other non-oral medications. The company develops and produces a broad portfolio of prescription and over-the-counter extended topical products—including creams, ointments, gels, foams, sprays, patches, nasal treatments, and suppositories—and specializes in Paragraph IV generic products that navigate branded patent complexities. Padagis also pursues research and development, strategic partnerships, product acquisitions, and contract manufacturing to support healthcare providers, distributors, and patients.

📋 Description

• Serve as the primary quality point of contact for assigned sterile-manufacturing CMOs/CDMOs • Own quality relationships across quality agreements, performance, and risk • Lead and participate in GMP, for-cause, and pre-approval CMO audits • Identify sterile-specific gaps in aseptic technique, environmental monitoring, media fill design, and terminal sterilization validation • Lead Quality and Technical aspects of drug product technical transfers • Build and interpret quality metrics and dashboards and drive corrective actions • Develop, negotiate, and maintain quality agreements • Review and approve CMO documentation supporting ANDA, PAS, and CBE submissions • Manage CMO deviations, CAPAs, and change controls • Identify and escalate CMO risks, including complaints, deviation and CAPA trends, quality-system maturity, and inspection history • Partner with Supply Chain, Regulatory Affairs, Operations, R&D, Legal, and other teams • Coach and influence CMO quality teams without formal authority • Mentor and cultivate talent within the Quality department • Support CDMOs during and after FDA inspections, including observation responses and remediation • Review and track CMO APRs • Perform other duties as assigned

🎯 Requirements

• 10–12+ years in pharmaceutical quality, with substantial hands-on experience in sterile manufacturing • Inhalation (MDI/DPI/nasal) and ophthalmic products specifically required • Bachelor's degree in a scientific discipline (chemistry, microbiology, pharmacy, engineering, or related) • Direct pharmaceutical sterile manufacturing experience • Working fluency in cGMP as applied to sterile operations: aseptic processing, environmental monitoring, sterility assurance, container-closure integrity, and terminal sterilization methods • Track record managing external manufacturing partners (CMO/CDMO) or supplier quality relationships • Experience supporting regulatory submissions (ANDA, NDA, PAS) from the quality side, including CMO-sourced technical content • Demonstrated ability to influence without formal authority • Strong written and verbal communication skills • Comfortable operating remotely and across time zones with distributed manufacturing partners • Up to 25% travel • Preferred: Advanced degree, audit leadership, and Quality Agreement ownership

🏖️ Benefits

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities • Affordable Access Done with CARE

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