Working @ Immatics

This position is responsible for all Quality Assurance department employees and manage all QMS operations and while driving a compliance focused culture at the site to meet all 21 CFR Part 820, 210 and 211 cGMP, ISO 13485:2016 and applicable international standards and regulations and safety procedures requirements. 

• Manage Change Controls, CAPAs and Deviations to ensure timely closeout
• Host and organize a weekly/biweekly Change control meeting to ensure change controls and evaluated for the Houston site
• Assist Change control owners to ensure compliance to the procedure
• Manage all Batch Record Printing /Authorized Copy Printing to support all activities for the Houston Site
• Maintain and Manage CV/Role Description and Onboarding/Personnel Training/Archiving (certificates etc)
• Responsible for Software administration (DocuSign, Enaio, QT9, etc.)
• Play a key role in implementation of the new eQMS System project
• Manage all controlled Documents Processing Requests and assign them appropriately to ensure no backlog 
• Manage new procedure related to the Weatherford site 
• Provide input in creating and managing Global Training matrix for QA/QMS Department 
• Develop, maintain the Training Program and ensure that effectiveness checks are performed for all facility personnel
• Develop and maintain QMS KPI/Metrix 
• Ensure facility compliance with 21 CFR Part 210 and 211 cGMP, 21 CFR Part 1270 and 1271 and applicable international standards and regulations and safety procedures.
• Develop, implement review and approve all change controls, protocols and specifications and other QMS records as required
• Develop, maintain and report all required QMS metrics and objectives
• Manage all vendor management investigations, change controls and complaint handling activities
• Support Internal and external audits program as required by Senior Management
• Manage quarterly audits in the QMS reporting results
• Assist with QMS department budget and staffing plans
• Prepare and implement annual department goals and objectives.
• Provide technical mentorship to staff
• Perform staff performance reviews and conducts one on ones
• Perform other duties as assigned
• Manage and improve Quality Management System (QMS) related department activities to ensure continues compliance

• Bachelor’s degree in a Life Science Discipline

• Six (6-10) years of relevant work experience
• Knowledge of regulatory compliance including 21 CFR Part 211.
• QA experience in the biotech and/or pharmaceutical industry
• Experience with OSHA regulations.
• Demonstrate internal auditing responsibilities.

• Strong organizational skills and detailed oriented.
• Strong technical writing skills.
• Ability to work independently to meet deadlines.
• Ability to manage all facility QA department activities and staff.

 

We are a committed and inspired company and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills. In addition, we offer:  

• Competitive Total Rewards package 

1. Base Salary  
2. Annual Bonus  

• Stock Options – based on position level  
• 401K plan with company match  
• Generous Holiday Time  
• Generous Paid Time Off (PTO) for ALL EMPLOYEES regardless of position level 
• Full Benefits 

1. Health Insurance  
2. Dental/Vision insurance   
3. Short-Term and Long-Term Disability  
4. Other voluntary insurance (Pet, Legal Shield Identity Theft Protection, Travel Assistant, Accidental Injury and Critical Illness,) 
5. Family Medical Leave 
6. Parental Leave  
7. Employee Assistance Program 

• Life Insurance policy  
• Additional Voluntary Life Insurance 
• Personal time with the CEO in your first 30 days  
• Collaborative and family environment 
• Monthly Site meetings with fun team building events 
• Participation in the annual Houston BioChili Cookoff  
• Themed Holiday party  
• Social Community Outreach participation  
• Development training and planning  
• Various committees to foster collaboration and involvement within Immatics  
• Hybrid work schedules (based on position need and supervisor’s approval) 

Recruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@immatics.com, and we will contact you if needed.   
 
Immatics values diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.

This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.