About the Job

We're hiring a Quality Assurance Manager to oversee tasks within Ossium Health's Quality Management System (QMS) in the production of human bone marrow-derived materials for pre-clinical and clinical use. The ideal candidate has a passion for and hands on experience with people in a Quality setting. In addition, they should bring a deep understanding of the theory, concepts, and regulations behind cGMP, CLIA, and AATB regulations.

As the QA Manager, you'll oversee, implement, and improve the Quality Management System to ensure we take a rigorous, thorough, and efficient approach to quality standards. In this role, you'll have the opportunity to work closely with colleagues in Quality Control, as well as Clinical Manufacturing and Clinical Production to understand our production processes and identify opportunities for improvement.

This position reports to the Senior Manager, Quality Systems.

Required Qualifications

• A BS or BA in biological sciences with 5+ years of experience in Quality Assurance including problem management, investigations, corrective actions, complaints, change control, document control, process improvement, supplier and materials management, records management, audits, training, and risk
• 3+ years in a QA people manager position with direct reports and responsibility for staffing decisions, performance management, and coaching
• Proven effective leadership skills and operation in a GTP, GMP, CLIA and/or AATB compliant operation
• Experience working in an electronic quality system
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• This position is based full time in our Indianapolis facility

Preferred Qualifications

• Experience with MasterControl electronic quality system
• Experience administering an electronic quality system
• Supplier auditing experience

Key Responsibilities

• Oversee operation of and monitor quality metrics pertaining to the following Quality Management Systems: problem management, investigations, corrective actions, complaints, change control, document control, process improvement, supplier and materials management, records management, audits, training, and risk
• Manage Quality Assurance Associates, Specialist, and Supervisors; provide guidance and support employee growth
• Investigate deviations, non-conformances, and results out of specification; recommend corrective actions
• Recommend and implement new or improved methods, procedures, and systems
• Use data to drive decisions and identify adverse trends before issues occur
• Back-up MasterControl System Administrator and support new module configurations
• Promote a culture of quality throughout the entire organization, educating and providing training on quality within and outside of the department

In your first six months some projects you'll work on include:

• Review current quality process and identify areas for improvement
• Improve material and supplier quality system by leading material specification establishment and supplier qualification
• Learn MasterControl to the level of System Administrator and participate in new module configurations
• Establish relationships within and outside the team to improve quality throughout the organization

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Generous paid time off + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements