ABOUT VGXI Inc.
VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers.
If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.
SUMMARY
The Quality Assurance Manager will primarily be responsible for quality assurance and compliance involving activities related to ensuring that production, testing, and associated documentation meets applicable regulatory requirements. This person will work with management and personnel to assess and ensure compliance with relevant regulatory requirements. They will also assist in organizing and directing Quality Assurance functions required to support product pre-approval activities, product post-approval activities as well as contract manufacturing / testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Help establish procedures for maintaining high standards of quality, reliability, and safety.
- Responsible for compliance with GMP/GLP/ISO and relevant government regulations.
- Responsible for batch record review, release, change control, deviations, etc.
- Responsible for generating/revising documentation (i.e.: Standard Operating Procedures and company quality policies).
- Review and approve manufacturing procedures, batch records, specifications, sampling plans, and labeling.
- Assess current qA policies, recommend process improvements and actions to promote corporate objectives. Coordinate and conduct internal and vendor audits.
- Act as a QA technical resource to assist with client and regulatory inspections, responses, issues, and submissions.
- Coordinate internal and vendor audits.
- Maintain current knowledge of regulatory requirements by attending appropriate seminars and/or continued learning activities.
- Managing QA / Validation / Document Control Personnel
EDUCATION and/or EXPERIENCE
Bachelor's degree from four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience.
BENEFITS
At VGXI, we recognize that our employees are at the heart of our success, and we offer exceptional benefits that reflect our commitment to their well-being. Our comprehensive offerings include a range of quality benefits, available to our employees from day one (no waiting period). Benefits include:
- Medical
- Dental
- Vision
- Life Insurance
- Short-Term and Long-Term Disability
- 401K Plan
- Flexible Spending Account
- Tuition Reimbursement
- Paid Time Off Including Holidays, Vacation and Sick/Personal Leave.
DIVERSITY, EQUITY AND INCLUSION
At VGXI, we are committed to recognizing and valuing you. Our diverse backgrounds, perspectives, and contributions fuel innovation and allow us to success both as individuals and as a team. We have established and embrace a culture of acceptance and inclusion with equity in recruiting, hiring, developing, and investing in talented people. Our commitment to these principles supports a diverse workforce and empowers us to achieve our mission of leading the industry in producing the next generation of therapeutics to improve patients’ lives.
Equal Opportunity Employer