Senior Pharmaceutical CMO Quality Account Manager

Minimum qualifications

• 10–12+ years in pharmaceutical quality, with substantial hands-on experience in sterile manufacturing: inhalation (MDI/DPI/nasal) and or ophthalmic products specifically required.
• Bachelor's degree in a scientific discipline (chemistry, microbiology, pharmacy, engineering, or related)
• Direct pharmaceutical sterile manufacturing experience: understand the plant floor, not just the quality system that governs it.
• 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: comfortable driving outcomes at partner organizations where you have no direct reporting line.
• Sharp, structured written and verbal communicator; able to distill technical risk into a business-relevant narrative for leadership.
• Comfortable operating remotely and across time zones with distributed manufacturing partners.

• Serve as the primary quality point of contact for assigned sterile-manufacturing CMOs/CDMOs, owning the relationship across quality agreements, performance, and risk.
• Lead and participate in CMO audits (GMP, for-cause, pre-approval) with the depth to identify sterile-specific gaps: aseptic technique, environmental monitoring trends, media fill design, terminal sterilization validation.
• Lead Quality and Technical aspects of drug product Technical Transfers of products from CMO to CMO or CMO into Padagis internal systems.
• Drive CMO performance through data: build and interpret quality metrics/dashboards, identify negative trends before they become deviations, and hold CMOs accountable to committed corrective actions.
• Own quality agreement development, negotiation, and maintenance for assigned accounts.
• Provide quality review and approval for CMO-generated documentation supporting ANDA, PAS, and CBE submissions, including sterile-specific technical sections (aseptic process simulation, container-closure, sterility assurance).
• Manage deviations, CAPAs, and change controls originating at CMO sites, ensuring root cause rigor and timely closure.
• Identify and escalate CMO risk proactively: post market complaint, deviation, CAPA effectivity trends, quality system maturity, regulatory inspection history.
• Partner cross-functionally with Supply Chain, Regulatory Affairs, and Operations to represent quality in CMO governance forums.
• Coach and influence CMO quality teams toward Padagis standards without formal authority over their staff as this role runs on credibility and relationship management, not org-chart leverage.

• Work with various teams such as Regulatory Affairs, R&D, Operations, and Supply Chain to embed quality considerations throughout all stages of product development and lifecycle phases.
• Mentor and cultivate talent within the Quality department, promoting a culture rooted in excellence and responsibility.

• Provide support to CDMO during and after FDA inspections and support them in observation responses and remediation of any observations.
• Support and provide QA and Technical direct input to Padagis Legal Team for matters involving CMO and/or externally manufactured Padagis products.
• Review and track APRs from CMOs and ensure complete reporting and no follow-ups are required.
• Other duties as assigned.