Location: Delaware
Reports To: Chief Quality Officer (CQO)
Position Overview
The Quality Assurance (QA) Manager will lead GMPLI’s quality oversight programs, ensuring all operations comply with GMP, FDA, and global regulatory standards. This role will be responsible for batch record review, change control management, audit coordination, and driving a culture of quality throughout the organization.
Key Responsibilities
- Oversee QA systems including deviation management, CAPAs, change controls, and document control.
- Review and approve master batch records, SOPs, and quality documentation.
- Lead internal audits and support regulatory inspections.
- Collaborate with Operations, QC, and Supply Chain to ensure compliance across all processes.
- Provide training on quality policies, procedures, and regulatory requirements.
- Monitor quality metrics and drive continuous improvement initiatives.
Qualifications
- Bachelor’s degree in Life Sciences, Quality Management, or related field.
- 5+ years QA experience in pharmaceutical, biotech, or healthcare manufacturing, with at least 2 years in a supervisory role.
- Strong understanding of GMP, FDA, and international quality standards.
- Experience in managing audits, CAPAs, and quality systems.
- Strong communication and leadership skills.
Key Competencies
- Regulatory Compliance
- Quality System Management
- Audit Preparedness
- Cross-Functional Collaboration
- Leadership & Training