Quality Manager, Batch & Donor Record Review

Ossium Health•Indianapolis, IN

8h•Hybrid

About The Position

This is a high-impact leadership role at the center of our quality operations. As the Quality Manager, Batch & Donor Record Review, you’ll lead the team responsible for donor eligibility and production batch record review within a 21 CFR 1271 and AATB-accredited environment, enabling the release of life-saving products to patients in need—where accuracy, judgment, and speed all matter. You’ll combine people leadership with deep technical expertise, applying risk-based decision making to support compliant, timely product release while continuously improving how quality partners with the business. You’ll work closely with Production, Operations, Supply Chain, Quality Systems, and Medical Directors to position quality as a strategic enabler. This role is ideal for someone who enjoys building strong teams, improving systems, delivering results, and making decisions that directly impact patient safety and operational success. This role reports directly to the Director, Quality Assurance.

Requirements

Bachelor’s degree in life sciences, healthcare, quality, or related field and 5+ years of experience in quality operations, donor eligibility, batch record review, or regulated manufacturing OR 10+ years of experience in quality operations, donor eligibility, batch record review, or regulated manufacturing
3+ years of people management or team leadership experience
Strong working knowledge of 21 CFR 1271, AATB Standards, and CLIA
Experience supporting product release decisions in a regulated environment
Experience working with Organ Procurement Organizations
Excellent documentation, organizational, and communication skills
This position is based in our Indianapolis office; you will report to Ossium’s facility Monday through Thursday and have the option to work remotely on Fridays
Qualified candidates must be legally authorized to be employed in the United States; Ossium is unable to provide sponsorship for employment visa status (eg, H-1B or TN status) for this position, either now or in the future

Nice To Haves

Experience in HCT/Ps, tissue banking, cell therapy, or biologics
Experience with CGMP
Familiarity with electronic QMS platforms (e.g., MasterControl)
Experience scaling review teams or processes in high-growth environments

Responsibilities

Lead, mentor, and develop a high-performing team responsible for batch and donor record review
Oversee donor eligibility determinations and production batch record review for product release
Apply risk-based decision making to deviations, discrepancies, and complex review scenarios
Ensure consistent compliance with internal procedures, 21 CFR 1271, and AATB Standards
Partner cross-functionally to resolve issues impacting quality and release timelines
Use metrics and trend data to drive continuous improvement and operational efficiency
Support inspection readiness, audits, and quality system activities