The QA Validation Manger will support all GMP validation activities for Immatics including computer systems validation (CSV), cleaning validation and equipment qualification for a new and existing facility. The QA Validation Lead will help members to assess new and changing computer systems to ensure compliance with company policies, procedures, and industry guidance.
- Extensive knowledge of ISPE GAMP5 and ASTM guidelines and proven experience with large and complex projects
- Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation
- The QA Validation lead will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions associated with site validation activities
- Provide Quality review on the Validation and Maintenance documents of computerized systems
- Review/revise CSV procedure and provide guidance and feedback to Global Quality units within Immatics
- Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc. for buildout of new facility)
- Provide assistance in assessing CSV changes on the preexisting and legacy equipment of Immatics.
- Participate in the Validation and Equipment Qualification program at the Immatics and act as QA SME for review and approval on validation documents
- Provide consistency in the validation approach for equipment, systems, computers, methods, and processes
- Review URS for new equipment, SOPs for equipment maintenance, cleaning, and calibration for each piece of equipment
- Perform change control assessments for existing QC and CMC-GMP equipment to ensure compliance with regulatory requirements in a phase appropriate manner
- Provide validation guidance/training to QA GMP Staff support cross-functional validation efforts and work closely with Global QA Function (CQA/QMS)
- Author, review and approve change control & Validation procedures for CMC and Facilities
- Perform and/or support validation activities, and trend, analyze, and interpret data to monitor performance and support revalidation decisions for changes
- Perform deviation investigations and resolutions through the CAPA system
- Understand emerging technologies (Cell and Gene Therapy) and apply knowledge in interest of Immatics
- Analytical and problem- solving skills, Attention to details and high level of accuracy
- Strong communication, technical writing, organizational and interpersonal skills
- Provide coaching to peers when questions arise and foster teamwork
- Be reliable and take the lead on projects
- Thorough knowledge of equipment lifecycle management, calibration, maintenance, cleaning and validation (IQOQPQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities.
- Expertise and working knowledge of cGMP guidelines and knowledge of Quality Systems that meets global regulatory expectations, including knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11 and GAMP 5 requirements, among others
Office, Labs, and Cleanroom EnvironmentsPhysical demands: Be flexible
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
Experience prolonged sitting, standing, walking, bending, stooping and stretching.
Use hand-eye coordination and manual dexterity sufficient to operate portable tools, as well as a computer keyboard, telephone, calculator, and other office equipment is required.
Have a normal range of vision.
May be required to lift up to 50 pounds on occasion. Climb ladders and stairs of various heights.
Be exposed to wet or humid conditions.
This position may include On-Call response for Facility issues.
Be exposed to outdoor weather conditions.
Be exposed to noisy environments.
Attendance is mandatory Travel required:
- Local travel may be required between facilities until all are combined
- Possible travel to Germany may be required for project alignment
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
- Base Salary
- 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
- Health Insurance
- Dental/Vision insurance
- Short-Term and Long-Term Disability
- Other voluntary insurance (Pet, Legal Shield Identity Theft Protection, Travel Assistant, Accidental Injury and Critical Illness,)
- Family Medical Leave
- Parental Leave
- 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 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 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.