Working @ Immatics

QA Manager

Permanent employee, Full-time · Houston (TX)

Overview
We are currently seeking a Full Time QA MANAGER to support our QUALITY ASSURANCE team. This position will work in Houston, Texas or remote from the East Coast. This position is responsible for all Quality Assurance department employees and manage all QA operations and QA manufacturing oversight activities 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. 
Your mission
The main responsibilities of this position will include but are not limited to the following tasks:
  • Manage all facility QA department activities and staff.
  • 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.
  • Manage all QA batch review and release activities and all label and material release control activities.
  • Oversee all raw materials receiving, sampling and release activities; and all in-process and finished product testing activities.
  • Oversee all facility failure investigation (OOS, OOT, NCR, CAPA and Deviation).
  • Ensure investigations are conducted and that the root causes are identified and eliminated.
  • 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.
  • Oversee the approved vendor and material list related to facility activities.
  • Manage all vendor management investigations, change controls and complaint handling activities.
  • Develop, maintain and continuously improve the Quality Management and Manufacturing Systems.
  • Develop, maintain the Training Program and ensure that effectiveness checks are performed for all facility personnel.
  • Review all facility and equipment work orders and subsequent change controls.
  • Assist in hosting FDA, Canada Health, European Union, ISO audits, internal audits, and external customer audits as required by Senior Management.
  • Support and execute risk management activities for existing products and new devices, if any.
  • Manage quarterly dose audits reporting results.
  • Assist with QA department budget and staffing plans.
  • Prepare and implement annual department goals and objectives.
  • Provide technical mentorship to staff
  • Perform staff performance reviews.
  • Perform other duties as assigned.
Your profile
The qualifications for this position include, but are not limited to the following:
  • Seven (7) 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
  • Bachelor’s or Master’s Degree in a Life Science Discipline.
  • 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.

Why us?
What Immatics Offers
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)
Notice
Notice to Third-Party Recruiters/Staffing Agencies 
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. 
About Us
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.