Manager, Quality Assurance | Donor Center in at Asterand Inc

HOW WE GOT HERE

For more than 40 years, BioIVT has evolved from a specialized biospecimen provider into a global partner to life science and diagnostic organizations. Our growth has been shaped by a consistent focus on helping researchers access the high-quality biospecimens, primary cells, ADME-Tox products, and research services they need to advance discovery, development, and medical progress.

What has remained constant throughout that history is our mission: to enable smarter science and accelerate medical breakthroughs that enhance and extend lives. Every BioIVT team member contributes to that mission, whether supporting a donor center, laboratory, commercial team, or corporate function. For employees, this means joining a company where scientific quality, operational excellence, compliance, collaboration, and customer focus all come together to support work that matters.

• Provide quality leadership and guidance to Donor Center operations, promoting a culture of compliance, accountability, and continuous improvement.
• Lead implementation, maintenance, and improvement of the Quality Management System to support regulatory compliance and business objectives.
• Oversee quality metrics, trend analysis, risk assessments, and performance monitoring to identify improvement opportunities and mitigate compliance risks.
• Lead Quality Management Reviews for assigned sites and ensure effective evaluation of quality system performance, audit results, customer feedback, risks, and improvement initiatives.
• Serve as the primary quality lead for customer audits, regulatory inspections, and compliance readiness activities.
• Review and approve deviations, nonconformances, complaints, investigations, CAPAs, and change controls, ensuring timely closure and effectiveness.
• Facilitate root cause investigations using risk-based and structured problem-solving methodologies.
• Participate in and provide guidance to Deviation Review Boards, Change Control Review Boards, Material Review Boards, and Quality Review Boards.
• Develop, review, and maintain SOPs and quality procedures to ensure standardized practices across Donor Centers.
• Oversee training program effectiveness and ensure personnel are qualified to perform assigned responsibilities.
• Support donor file review, product disposition, and release activities to ensure compliance with regulatory, quality, and customer requirements.
• Conduct internal audits, facility inspections, and quality system assessments to verify ongoing compliance and identify improvement opportunities.
• Review and approve equipment, process, computerized system validation, and qualification activities as assigned.
• Maintain QA records and documentation in accordance with record retention and archival requirements.
• Partner with clients, suppliers, and cross-functional stakeholders to provide quality and regulatory guidance that supports organizational goals.

• Strong knowledge of Quality Management Systems, GMP, GDP, quality risk management, and regulatory compliance.
• Experience leading investigations, CAPA programs, audits, inspections, and quality improvement initiatives.
• Knowledge of applicable FDA, state, and industry regulations governing donor center, laboratory, biologics, or tissue-related operations.
• Excellent leadership, communication, organizational, and problem-solving skills.
• Demonstrated ability to influence cross-functional teams and drive compliance in a dynamic operational environment.

Hybrid Position

• Employee must maintain a dedicated home workspace and reliable internet connection when working remotely.
• Expected onsite presence of at least three (3) days per week.
• Travel to donor centers and other company locations approximately once per month or as business needs require.

ALSO TRUE OF THE RIGHT PERSON

• You are mission-driven and take pride in contributing to work that helps advance science, medical progress, and better outcomes.
• You value collaboration and build trusted relationships by being respectful, responsive, and solutions-oriented.
• You bring a strong sense of ownership and accountability, following through on commitments and taking pride in the quality of your work.
• You are comfortable working in a fast-paced, growing organization where priorities can shift and good judgment, flexibility, and communication matter.
• You care about doing things the right way, with consistency, integrity, attention to detail, and respect for quality and compliance.
• You are curious, open to feedback, and committed to continuous improvement in how we work, learn, and grow together.

WHAT WE OFFER

• Comprehensive medical coverage with PPO/HRA and HDHP/HSA plan options.
• Company-funded HRA or HSA contributions, depending on the medical plan elected.
• Prescription drug coverage, virtual care through MDLIVE, and preventive care
• Dental coverage through Cigna and vision coverage through VSP.
• Company-paid life, AD&D, short-term disability, and long-term disability coverage.
• Flexible spending account options, including healthcare, limited purpose, and dependent care FSAs.
• 401(k) retirement plan with employer Safe Harbor matching contributions.
• Tuition reimbursement to support continued learning, professional growth, and career development.
• Paid time off, company-paid holidays, employee assistance resources, travel assistance, and voluntary benefit options.

EQUAL OPPORTUNITY AND BELONGING

At BioIVT, our mission to enable smarter science and accelerate medical breakthroughs is strengthened by the people who bring that work to life. We are committed to building a workplace where employees are treated with fairness, respect, and dignity, and where different experiences, perspectives, and ideas help us better serve our customers, partners, donors, and one another. BioIVT is proud to be an Equal Opportunity Employer and welcomes qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, genetic information, or any other status protected by applicable law. We are proud to be an Equal Opportunity Employer.

To Learn more about our mission and team culture, click here!