[Hiring] Senior Pharmaceutical CMO Quality Account Manager @Padagis LLC

Role Description

Padagis is hiring a Senior CMO Quality Account Manager to own the quality relationship for a portfolio of sterile and non-sterile manufacturing partners. This is an account-management role at heart: you are the single point of quality accountability for one or more CMOs, responsible for the performance, risk posture, and regulatory readiness of that relationship end to end. You will carry deep sterile manufacturing expertise into a role that requires influence more than authority — driving CMO performance without owning their operations.

We are specifically looking for candidates with hands-on sterile manufacturing background in inhalation or ophthalmic products as well as topical/transdermal non-sterile products. This is not a generalist CMO quality role — the technical fluency to challenge a CMO on aseptic process design, container-closure integrity, or particulate control is a requirement, not a differentiator.

• 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.

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.

Preferred Qualifications

• Advanced degree.
• Audit leadership and Quality Agreement ownership.

Key Competencies in Action

• Service Delivery: Own the quality relationship with CMOs by ensuring compliance with quality agreements, driving performance metrics, and proactively identifying and addressing risks to maintain regulatory readiness.
• Active Collaboration: Partner cross-functionally with teams such as Supply Chain, Regulatory Affairs, and Operations to embed quality considerations throughout all stages of product development, technical transfers, and lifecycle management.
• Demonstrate Agility: Adapt quickly to changing circumstances by proactively managing CMO risks, implementing effective CAPA strategies, and addressing audit findings to protect product integrity and regulatory standing.
• Excellent Execution: Provide precise quality reviews and approvals for technical documentation, lead sterile-focused GMP and pre-approval audits, and ensure alignment with Padagis standards through diligent oversight and accountability.
• Think Differently: Leverage deep expertise in sterile manufacturing to challenge conventional practices, identify gaps in aseptic processes, and propose innovative strategies for driving continuous improvement in CMO operations.