QA Manager

Headquartered in Morrisville, NC, Synoligo Biotechnologies is a Contract Research Organization (CRO) focused solely on the research, development, and manufacturing of diagnostic and therapeutic oligonucleotides. We provide fast, one-stop services with high-end preclinical solutions and CMC consultancy. We help our customers navigate any CMC issue they may encounter, whether it's starting raw materials or final product manufacturing for clinical trials. At Synoligo, we pride ourselves on being trusted partners in the discovery and development of life changing drugs. Join our team and help move science forward

As the QA Manager you will be in charge of building our quality operations, ensuring compliance with IVD regulations and broader organizational quality standards.

What you'll do in this role

· Develop, implement, and maintain ISO 13485 and ISO 9001-compliant QMS policies and procedures.

· Ensure compliance with FDA 21 CFR Part 820, EU MDR, and other applicable global regulatory requirements.

· Lead internal, supplier, and external audits, including certification and surveillance audits.

· Manage and mentor the growing QA team, promoting accountability and excellence.

· Provide training on ISO 13485 and ISO 9001 standards, regulatory requirements, and best practices.

· Identify and resolve quality gaps through corrective and preventive actions (CAPA).

· Drive continuous improvement initiatives to enhance efficiency, reduce risk, and improve product quality.

· Oversee document control, change management, and record-keeping systems.

· Ensure proper validation and verification of processes, equipment, and software

· Partner with R&D, manufacturing, supply chain, and regulatory affairs teams to ensure quality integration across product lifecycle.

· Support new product development with quality oversight and compliance guidance.

What you bring to the table

· Bachelor's degree in Engineering, Life Sciences, or related field.

· Minimum 5+ years of experience in Quality Assurance, with at least 2 years in a managerial role.

· Proven expertise in ISO 13485 and ISO 9001 QMS implementation and maintenance, knowledge of oligonucleotide for use in IVD or molecular diagnostic is preferred.

· Strong knowledge of FDA, EU MDR, and other international regulatory requirements.

· Experience leading audits (internal, supplier, regulatory).

· Excellent leadership, communication, and problem-solving skills.

What we offer you

· Competitive Compensation

· Medical, Dental and Vision Insurance

· 401k with Company Match

· Paid Time Off (PTO)

· Flexible work schedule

· The opportunity to help build a department, influence policy and be a part of a team doing impactful work

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending