Senior Pharmaceutical CMO Quality Account Manager

Responsibilities

The Senior CMO Quality Account Manager serves as the primary quality point of contact for assigned sterile-manufacturing partners, overseeing quality agreements, performance, and regulatory readiness. They are responsible for leading audits, managing technical transfers, and driving continuous improvement through data-driven oversight and cross-functional collaboration.

Requirements

Candidates must have 10-12+ years of pharmaceutical quality experience with specific hands-on expertise in sterile manufacturing, particularly inhalation or ophthalmic products. A bachelor's degree in a scientific discipline is required, along with a proven track record in managing external manufacturing partners and influencing without formal authority.

Skills

• Sterile manufacturing
• Quality management
• CMO/CDMO management
• Aseptic processing
• Regulatory compliance
• cGMP
• Technical transfer
• Risk management
• Audit leadership
• Inhalation products
• Ophthalmic products
• CAPA
• Deviation management
• Quality agreements
• Sterility assurance
• Container-closure integrity

About this role

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.

Job duties: 

* 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.

 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.

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 d...

About Padagis LLC

Pharmaceutical Manufacturing · 201-500 employees · headquartered in Allegan, MI