We are currently seeking a
Clinical Quality Assurance Manager
to support our team. This position will work in Houston.
This position will work in Houston, Texas and will play a key role in the day-to-day operational US procurement activities of the business.
The main responsibilities of this position will include but are not limited to the following tasks:
- Implement and maintain QA systems related to Immatics clinical trials (GCP QA function):
- Plan, conduct and follow-up of trial related audits, e.g. audits of documents, investigator sites, systems and processes, vendors.
- Support preparation and hosting of regulatory inspections.
- Organize and deliver GCP and quality related training to company personnel.
- Provide support to Clinical functions regarding vendor selection, qualification and oversight, Change Controls, GCP and protocol deviations, CAPAs and SOPs.
- Interface with GMP QA (GMP QA function):
- Provide support in batch release and product complaints.
- Provide support with internal audits of IMP manufacturing and testing.
- Provide support in documentation review, including but not limited to validation documents, stability studies, deviations, batch records, and test records.
The qualifications for this position include, but are not limited to the following:
REQUIRED: Bachelor’s Degree in Life Sciences or related discipline.
- REQUIRED: University degree in natural sciences/engineering/quality management.
- 3+ years working for life sciences companies in a clinical quality position.
- In-depth knowledge of GCP requirements is a must, GMP knowledge is preferred.
- Experience including external/CRO, clinical/regulatory and document auditing highly desirable.
- Demonstrate leadership abilities.
- Ability to demonstrate strong analytical and problem-solving skills.
- Strong written and verbal communication skills.
- Must be results oriented, multi-tasking, quick learner, respond to urgent needs of the team and show a strong track record of meeting deadlines.
What We Offer
We are a committed and inspired team 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: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g. job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
We are a committed and inspired team 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. Immatics offers partial subsidized health, dental and vision insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance.
If you’re interested in working for Immatics, please forward your CV along with a letter of introduction via e-mail to RecruitingUS@immatics.com. For more detailed information about Immatics and privacy protection visit www.immatics.com.
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@imamtics.com, and we will contact you if needed.