You will manage key components of the Quality Management System while providing guidance to QA staff and collaborating with organizational and project leadership to maintain high standards of quality and compliance. Your responsibilities will include:
Manage assigned components of the Quality Management System, such as the internal auditing program, document control, and Corrective and Preventive Action (CAPA) processes.
Supervise and support members of the Quality Assurance Department, as applicable.
Review and approve audit reports, ensuring findings are accurately documented and addressed.
Develop and maintain the internal audit schedule.
Lead client audits and regulatory inspections, coordinating preparation, responses, and follow-up activities.
Conduct internal and vendor audits as needed to assess compliance and operational effectiveness.
Draft, review, and update quality assurance policies and procedures.
Review and approve corporate Standard Operating Procedures (SOPs), as required.
Contribute to organizational process improvement initiatives and strengthen quality management practices.
Prepare Quality Management reports for QA leadership and internal stakeholders.
Deliver corporate quality and compliance training when required.
Communicate quality concerns, audit findings, and compliance issues to QA and organizational management.
Perform additional responsibilities as assigned while ensuring compliance with applicable company policies and standards.
Requirements
The ideal candidate is an experienced quality assurance professional with a strong background in regulated environments, proven management capabilities, and the ability to influence stakeholders across different organizational levels. The following qualifications are required or preferred:
Bachelor’s degree in Life Sciences or a related scientific field.
7–9 years of experience working in a regulated environment, such as GxP or ISO-regulated operations.
Previous management experience.
Strong understanding of quality management systems, regulatory compliance, auditing, and quality assurance practices.
Experience managing or contributing to internal audits, vendor audits, CAPA programs, document control, and SOP governance.
Ability to prioritize critical tasks, respond promptly to day-to-day needs, and adapt to unexpected organizational requirements.
Strong interpersonal, negotiation, and influencing skills, with the ability to work effectively with stakeholders at all organizational levels.
Excellent organizational skills, attention to detail, and ability to manage multiple responsibilities simultaneously.
Strong written and verbal communication skills, combined with effective problem-solving abilities.
Proficiency in Microsoft Office.
Preferred Qualifications
Professional quality certifications such as Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), Regulatory Affairs and Quality Assurance Professional (RQAP), or Six Sigma certification.
Location Requirements
Remote position open to candidates based in the United States.
The role is particularly associated with the Northern Virginia, Maryland, and Washington, DC areas.
Benefits
Flexible approved time off.
Tuition reimbursement.
401(k) retirement plan.
Work-from-home flexibility anywhere in the United States.
Maternal and paternal leave.
Casual dress code and work environment.
Opportunities to contribute to global public health initiatives.
Community engagement and volunteer opportunities through an employee-focused community program.
Competitive benefits package designed to support employee health and well-being.
How Jobgether works
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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