Our advice- run this job description AND your resume through AI- and see what the Employer's ATS will flag and evaluate if you are a match.
If you're aiming for a job like this, you need an edge.
Our JobsAI tool gives you that edge—by helping you upgrade your resume, analyze hiring managers’ LinkedIn profiles, and prepare with a built-in interview coach.
Get a FREE trial and see for yourself!
👉
Check out JobsAI Sr. Manager, Quality Management Systems
Company Name: Immunome, Inc.
Job Overview
The Sr. Manager, Quality Management Systems will play a key leadership role in the design, deployment, and continuous improvement of Immunome’s Quality Management System (QMS). Reporting to the Head of Quality Systems, this role will be responsible for ensuring the effective implementation and oversight of core quality system elements, including GxP document control, records management, and training administration. This position requires cross-functional collaboration and vendor oversight to support quality and regulatory compliance from early development through commercialization.
Responsibilities
- Serve as the process owner for GxP-controlled document and records management
- Develop, implement, and maintain SOPs, templates, and controlled workflows in the electronic Document Management System (eDMS/eQMS)
- Ensure controlled documents are current and updated
- Lead system optimization efforts
- Provide quality oversight for manufacturing and quality records
- Own GxP training processes and systems
- Define and maintain training requirements and curricula
- Develop and deliver training
- Oversee training compliance tracking and reporting
- Support training effectiveness strategies
- Contribute to strategic direction of Quality Systems
- Identify and implement process improvements
- Define and monitor quality metrics and KPIs
- Support inspection readiness
- Lead continuous improvement initiatives
- Serve as SME during audits and inspections
- Support Quality Management Review
- Collaborate with IT, Regulatory, Clinical, and Technical Operations teams
- Participate in implementation and configuration of additional QMS modules
- Support other compliance and quality initiatives
Qualifications
- Bachelor’s degree in life sciences or equivalent
- Minimum 7 years of experience in regulated biotech or pharma, with at least 3 years in QMS and/or Document and Training Administration
- Proficiency in Microsoft Applications
- Experience with validated GxP Document Management and Training Systems
- Proficiency with electronic QMS platforms
- Expertise in GxP training programs
- Knowledge of data integrity principles
- Strong continuous improvement mindset
- Understanding of FDA, EMA, ICH regulations
- Experience supporting clinical and commercial-stage programs
- Excellent project management and communication skills
- Experience with biologics and ADCs is desirable