Location: Houston, TX
Department: Quality Assurance
Reports to: Head of Quality Assurance
Responsibilities- Serve as a Quality Operations leader providing quality oversight and support for GMP manufacturing operations, ensuring compliance with regulatory requirements, company procedures, and quality standards.
- Perform and approve batch disposition decisions for raw materials, intermediates, and drug products, ensuring timely and compliant product release.
- Lead comprehensive review and approval of batch production records, laboratory records, and associated GMP documentation to ensure accuracy, completeness, and adherence to cGMP requirements.
- Manage quality records including deviations, CAPAs, change controls, investigations, and other quality system records, ensuring timely closure and effective resolution.
- Provide quality oversight of aseptic manufacturing operations, ensuring adherence to contamination control strategies, aseptic techniques, and GMP behaviors.
- Partner closely with Manufacturing, Quality Control, Supply Chain, Validation, and Technical Operations to proactively identify and resolve quality and compliance issues.
- Participate in quality review boards and cross-functional governance meetings, providing risk-based recommendations and quality leadership.
- Author, review, revise, and approve SOPs, work instructions, specifications, and quality system documents.
- Support inspection readiness activities and participate in regulatory inspections, customer audits, and internal audits.
- Drive continuous improvement initiatives focused on compliance, efficiency, quality metrics, and operational excellence.
- Support onboarding, training, mentoring, and development of Quality Operations team members.
- Perform other duties and responsibilities as assigned.
Qualifications & Skills- Bachelor's degree in a scientific discipline (Biology, Chemistry, Biochemistry, Biotechnology, or related field) required.
- Minimum of 5-7 years of Quality Assurance experience in a regulated pharmaceutical, biotechnology, or cell and gene therapy environment
- 1-3 years of supervisory or management experience preferred.
- Demonstrated leadership abilities with experience coaching, mentoring, and developing team members.
- Basic understanding of Cell and Gene Therapy manufacturing processes and quality systems preferred.
- Experience supporting Quality Assurance activities within manufacturing, quality control, and/or quality systems operations.
- Working knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable GxP regulations.
- Familiarity with applicable regulatory requirements, industry guidance documents, and quality standards.
- Effective interpersonal skills with the ability to collaborate across cross-functional teams.
- Excellent organizational skills and attention to detail.
- Ability to prioritize multiple tasks and manage competing deadlines in a fast-paced environment.
- Strong verbal and written communication skills.
- Strong analytical and problem-solving skills.
- Proficiency with Microsoft Office Suite and quality management systems (e.g., electronic document management systems, deviation and change control systems).
Working Conditions, Equipment, and Physical DemandsThis position primarily operates in an office environment but may require periodic presence in manufacturing, laboratory, warehouse, and quality control areas to provide quality oversight and support.
Equipment Used- Computer, printer, telephone, and other standard office equipment.
Physical Requirements- Prolonged periods of sitting and working at a computer workstation.
- Ability to occasionally lift and move items weighing up to 15 pounds.
- Ability to gown and enter controlled manufacturing environments when required.
- Ability to perform activities within manufacturing suites, warehouse areas, and raw material storage areas as needed.
The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.
