Job Details

Company Description

Job Description

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.

Key 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

Qualifications

Qualifications

• 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)

Preferred

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

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $123,000 - $169,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.