Senior Quality Assurance Investigations Specialist - Second Shift

Immatics•Houston, TX

33d•Onsite

About The Position

J oin Immatics and s hape the f uture of c ancer i mmunotherapy ; one patient at a time ! Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME , a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics . Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patient s globally . We are seeking a Senior Quality Assurance Investigations Specialist to support our Operational Quality Assurance and Systems team. The Senior Quality Assurance Investigations Specialist is responsible for overseeing quality events for the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies . This role involves independently authoring and resolving deviations, driving process improvements, and managing complex deviation investigations. The ideal candidate will effectively communicate across multiple groups and levels to drive deviation closure and support the overall quality assurance strategy.

Requirements

Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field.
Experience (5+ years) in quality assurance, preferably within the cell and gene therapy industry, or biopharma with a focus in batch release and Deviation writing and approval.
At least 6+ years of Biotechnology and/or pharmaceutical industry experience is .
Strong knowledge of regulatory requirements and guidelines specific to cell and gene therapy products, such as FDA regulations, EMA guidelines, and ICH guidelines.
Familiarity with relevant standards, such as cGMP (current Good Manufacturing Practice) and GCP (Good Clinical Practice).
In-depth understanding of cell and gene therapy manufacturing processes, including cell culture, gene delivery systems, and viral vectors.
Proficient in reviewing and interpreting analytical data, batch records, and technical documentation related to cell and gene therapy products.
Experience in managing deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.
Ability to make sound decisions and approach problems with curiosity and open-mindedness .
High degree of independent working, analytical reasoning, and the ability to communicate effectively .
Careful editing and documenting results .
Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence .
Ability to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills .
Ability to effectively collaborate with members from other departments .
Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 keypad , touch screens, and others.
Lifting - raising or lowering an object (up to 25 lbs. ) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.
Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
Pushing - Exerting force upon an object so that the object moves away from the object.
Pulling - Exerting force upon an object so that the object moves toward the force.
Sitting – remaining in a sitting position for at least 50% of the time.
Standing/Walking - remain on one's feet in an upright position at a workstation.
Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Legal eligibility to work in the United States is .
Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment

Nice To Haves

Master’s degree or higher preferred .

Responsibilities

Independently author /r eview d eviations in order to meet Batch release requirements for cell and gene therapy product .
Focus on deviation closeout and providing resolution by ensuring timely identification, investigation, and closure of deviations, including root cause analysis and implementation of effective corrective and preventive actions (CAPA).
Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.
Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.
Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes.
Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release.
Communicate across multiple groups and levels to drive deviation closure and provide regular progress updates.
Identify interdepartmental process improvements and work cross-functionally to implement them.
Utilize advanced root cause analysis techniques and technical impact analyses during the deviation investigation process.
Manage multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of the organization.
Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information.
Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation.
Participate in the training process and coaching of new team members and processes.
Assist with metric reporting and workload management to meet the team’s priorities.
Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices.
Contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products.
Identify opportunities for process improvements, risk mitigation, and increased efficiency in the batch release process.
Stay up to date with the latest advancements, regulations, and best practices in the field of cell and gene therapy manufacturing and quality assurance.

Benefits

Comprehensive Benefits : Competitive rates for Health, Dental, and Vision Insurance
4 weeks of P aid Time off, granted up front each year and prorated for first and last year of employment.
Sick Time Off – 56 hours
12 Paid Holidays
100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K ( club together)
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibility & company mat ch… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employmen t , 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
P artially paid Parental Leave for eligible employees. (3 weeks)
Additional voluntary employee paid coverages including Accident , Hospital Indemnity, and Critical Illness
Employee Paid Identity Theft Protection and Pet Insurance .
Professional Growth : Opportunities to work with leading experts in the field of T-cell immunotherapy.
Company provided learning and development opportunities
Fast paced, high demand collaborative and dynamic environment.