Senior Pharmaceutical Quality Account Manager

This is a fully remote position, open to applicants in Arizona, +13 more states.

📋 Description

• Act as the main quality liaison for designated sterile-manufacturing CMOs/CDMOs.

• Manage quality relationships encompassing quality agreements, performance metrics, and risk assessment.

• Lead and engage in GMP, for-cause, and pre-approval audits for CMOs.

• Detect sterile-specific deficiencies in aseptic techniques, environmental monitoring, media fill design, and validation of terminal sterilization.

• Oversee Quality and Technical elements related to the technical transfer of drug products.

• Create and analyze quality metrics and dashboards, driving necessary corrective actions.

• Establish, negotiate, and uphold quality agreements.

• Review and authorize CMO documentation relevant to ANDA, PAS, and CBE submissions.

• Manage CMO deviations, CAPAs, and change control processes.

• Recognize and escalate risks associated with CMOs, including complaints, trends in deviations and CAPAs, quality system maturity, and inspection records.

• Collaborate with Supply Chain, Regulatory Affairs, Operations, R&D, Legal, and other departments.

• Mentor and influence CMO quality teams without formal authority.

• Develop and nurture talent within the Quality department.

• Assist CDMOs during and post-FDA inspections, including responses to observations and remediation efforts.

• Review and monitor CMO Annual Product Reviews (APRs).

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• 10–12+ years of experience in pharmaceutical quality, with significant hands-on involvement in sterile manufacturing.

• Experience with inhalation (MDI/DPI/nasal) and ophthalmic products is specifically required.

• Bachelor's degree in a scientific field (chemistry, microbiology, pharmacy, engineering, or a related discipline).

• Direct experience in pharmaceutical sterile manufacturing.

• Proficient understanding of cGMP as it pertains to sterile operations: aseptic processing, environmental monitoring, sterility assurance, container-closure integrity, and terminal sterilization techniques.

• Proven history of managing relationships with external manufacturing partners (CMO/CDMO) or supplier quality alliances.

• Experience in supporting regulatory submissions (ANDA, NDA, PAS) from the quality perspective, including technical content sourced from CMOs.

• Proven ability to influence without formal authority.

• Excellent written and verbal communication skills.

• Comfortable working remotely and across multiple time zones with distributed manufacturing partners.

• Willingness to travel up to 25% of the time.

• Preferred qualifications include an advanced degree, experience in audit leadership, and ownership of Quality Agreements.

🏝️ Benefits

• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.

• Affordable Access Done with CARE.