Manager, Quality Systems and Compliance

Deciphera Pharmaceuticals • Waltham, MA

2d • Remote

About The Position

We are seeking a Manager, Quality Systems & Compliance to support the development and commercialization of innovative therapies by ensuring robust quality systems and regulatory compliance. This role plays a key part in managing core elements of the Quality Management System (QMS) and partnering cross-functionally to maintain compliance with global regulations (FDA, EMA, ICH, and other standards).
The ideal candidate will bring strong GMP expertise and hands-on experience with quality systems, including Change Controls, Quality Events, and Annual Product Quality Reviews (APQRs). This individual will coordinate critical quality processes, drive operational efficiency, and support quality oversight across the organization.

Requirements

• Bachelor’s degree with 5+ years of experience in Quality Systems or Quality Assurance within pharma/biotech
• Strong knowledge of GMPs, including Change Control, Quality Events, and APQR processes
• Experience with Veeva Vault Quality Suite or similar eQMS platforms
• Proven analytical, problem-solving, and project management skills
• Excellent communication skills with the ability to collaborate across technical and non-technical teams
• Proficiency in Microsoft Office (Excel, PowerPoint, Word, Outlook)

Nice To Haves

• Strong organizational and operational mindset with attention to detail
• Project management experience
• Collaborative approach with excellent written and verbal communication skills

Responsibilities

• Lead Change Control processes, including intake, coordination of review boards, tracking, and reporting of key metrics
• Manage Quality Event records (e.g., deviations), including tracking, reporting, and facilitating cross-functional review meetings
• Coordinate and oversee the APQR process, ensuring timely review, approval, and documentation
• Support Quality Management Review meetings, including scheduling, content development, and follow-up on action items
• Partner with internal teams to ensure alignment and continuous improvement of quality systems and processes
• Assist other QS&C Team Members with routine activities

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees