Manager - Quality Assurance Operations (Contractor)

Job Title: Manager - Quality Assurance Operations (Contractor)

Location: Remote (East Coast preferred, hybrid for local candidates)

Experience Required: 5-7 years

Overview:

We are seeking a Manager of Quality Assurance Operations to join our DP/CMC/Alliance QA Operations team. This contractor role is focused on providing support for all GMP aspects of drug product (DP) manufacturing, CMC, and alliance management. The position requires a hands-on approach to operational quality oversight, ensuring compliance with cGMP regulatory requirements from clinical through commercial lifecycle activities. This role reports directly to the Director of Quality Assurance.

Key Responsibilities:

• Oversee quality processes for external manufacturing of clinical and commercial drug products, including lot disposition.
• Review and approve Deviations, Change Controls, and CAPAs for both internal and external operations.
• Provide QA support for review and data verification in clinical regulatory filings.
• Collaborate with alliance partners to ensure compliance with quality systems and practices related to drug product manufacturing and disposition.
• Establish and promote best practices in partnership with internal teams and external vendors.
• Resolve complex quality issues through compliant, patient-centric solutions.
• Monitor and report timely, accurate metrics for KPI tracking and risk register management.
• Drive continuous improvement initiatives to mitigate risks and enhance operational effectiveness.

Qualifications:

• Bachelor's degree in life sciences, engineering, or a related field.
• 5+ years of experience in pharmaceutical or biopharmaceutical Quality Assurance roles with increasing responsibility.
• Proven experience working with external Contract Manufacturing Organizations (CMOs) in a virtual setting.
• Knowledge of aseptic techniques and parenteral drug manufacturing operations.
• Hands-on GMP management experience, including exposure to FDA, EMA, PMDA, ANVISA, or similar regulatory authorities.
• Familiarity with investigational and commercial products in a Quality Operations role is preferred.
• Experience collaborating with Alliance Partners is a plus.
• Demonstrated ability to streamline processes and improve turnaround times.
• Proficiency in Veeva Quality and SAP is essential.

If you are a detail-oriented professional with a passion for maintaining high-quality standards in pharmaceutical operations, we encourage you to apply today!