Senior Specialist, Quality Systems

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities to improve lives.

Requirements

• Bachelor’s Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)
• Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation
• Thorough knowledge and application of Good Documentation Practices (GDP)
• Experience in a GxP environment
• Must be self-motivated, organized, and proactive
• Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements/guidance documents

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Paid time off
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 401(k) with company match
• Employee discounts
• Onsite fitness facility
• Mental health counseling and financial planning services
• Employer-paid short and long-term disability coverage