Quality Manager, Batch & Donor Record Review

About the Job

This is a high-impact leadership role at the center of our quality operations. As the Quality Manager Batch & Donor Record Review youll 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 needwhere accuracy judgment and speed all matter.

Youll 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. Youll 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.

Required Qualifications

• Bachelors 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 Ossiums 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

Preferred Qualifications

• 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

Key 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

In your first six months some projects youll work on include:

• Building strong relationships across Quality Operations and Medical Director teams
• Assessing and strengthening donor and batch record review workflows
• Evaluating team training workload and metrics to support growth
• Implementing clearer more consistent risk-based review practices
• Helping scale processes to support increasing volume without sacrificing quality
• Playing a visible role in inspection readiness and quality system maturity

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements