Supervisor, Quality Assurance

Welcome to Disc Genics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment.

At Disc Genics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting-edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort.

Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do.

Join us at Disc Genics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past.

Discover more about us at  and see how you can contribute to revolutionizing patient care through regenerative therapies.

Job Summary:

The Quality Assurance (QA) Supervisor is responsible for leading and maintaining the Quality Management System (QMS) to ensure compliance with FDA, EMA, ICH, and other global regulatory requirements applicable to biopharmaceutical development, manufacturing, testing, packaging, and distribution. This role provides quality oversight of GMP operations, manages quality systems, supports regulatory inspections, and promotes a culture of quality and continuous improvement across the organization.

The QA Supervisor partners closely with Manufacturing, Quality Control, Regulatory Affairs, Validation, Supply Chain, and Technical Operations to ensure products are manufactured and released in compliance with applicable regulations, company procedures, and quality standards.

This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the Disc Genics Values.

Essential Duties and Responsibilities:

Quality Management System

• Manage and maintain the company’s Quality Management System (QMS) in compliance with current Good Manufacturing Practices (cGMP).
• Oversee quality systems including:
  • Deviations
  • CAPAs (Corrective and Preventive Actions)
  • Change Control
  • Complaints
  • Internal Audits
  • Document Control
  • Supplier Quality Management
  • Training Compliance
• Monitor quality metrics and identify opportunities for continuous improvement.

GMP Compliance and Quality Oversight

• Provide QA oversight for manufacturing, laboratory, packaging, and warehouse operations.
• Ensure compliance with FDA and other applicable regulatory requirements.
• Review and approve GMP documentation, including batch records, protocols, reports, specifications, and SOPs.
• Assess quality risks and ensure appropriate mitigation strategies are implemented.

Investigations and CAPA Management

• Lead and approve investigations related to deviations, out-of-specification (OOS) results, out-of-trend (OOT) results, and customer complaints.
• Ensure timely completion of root cause analyses and effective CAPA implementation.
• Evaluate CAPA effectiveness and monitor closure activities.

Audits and Regulatory Inspections

• Plan, conduct, and manage internal quality audits.
• Support supplier qualifications and vendor audits.
• Prepare the organization for regulatory inspections.
• Act as the primary QA representative during inspections and coordinate responses to audit findings.

Product Release and Documentation

• Ensure proper review and approval of batch production and testing records.
• Support product disposition and release activities in accordance with established procedures.
• Verify the completeness, accuracy, and compliance of GMP documentation.

Leadership and Team Development

• Lead, coach, and develop QA personnel.
• Establish performance goals and development plans for team members.
• Foster a quality-focused culture emphasizing compliance, accountability, and operational excellence.
• Collaboration cross-functionally to drive quality initiatives and business objectives.
• Identify and implement process improvements that enhance quality, efficiency, and regulatory compliance.
• Analyze quality trends and recommend corrective actions to prevent recurring…