Quality Manager

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

The Quality Manager leads implementation of quality assurance programs and ensures that laboratory operations and documentation meet GLP, ISO, and DoD regulatory requirements. Establishes and oversees quality systems ensuring compliance with regulatory and organizational standards in support of research and diagnostics.

Essential Job Functions:

• Develop, implement, and monitor quality control processes.
• Conduct internal audits and corrective action reviews.
• Train personnel on QA policies and GLP principles.
• Maintain SOPs and QA/QC documentation systems.
• Coordinate inspections and regulatory reporting.

Necessary Skills and Knowledge:

• Knowledge of GLP, ISO 9001/13485, and FDA/DoD regulations.
• Strong auditing and root cause analysis skills.
• Experience with CAPA and deviation management.
• Excellent leadership and process improvement skills.
• Shall have the ability to analyze these extremely complex problems and recommend, monitor and execute best practice solutions to executive level management.
• Possesses good written and oral communication skills, along with the ability to work well in teams.

Minimum Qualifications:

• Bachelor's degree in quality assurance, regulatory science, or life sciences.
• Minimum 8+ years in quality systems in biomedical or regulatory environments.
• Ability to obtain and maintain a SECRET security clearance eligibility, with no access to classified information, is required.
• Enroll in the Personnel Reliability Program (PRP), if required.

Preferred Qualifications:

• ACTIVE SECRET is preferred
• ASQ CQE/CQA certification or advanced degree preferred.

Pay and Benefits

The annual salary range for this position is $150,000 - $185,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.