Quality Compliance Senior Manager at Texas Biomedical Research Institute

San Antonio, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Sep, 26

Salary

0.0

Posted On

26 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Regulatory Compliance, Team Leadership, Supervisory Skills, Project Management, Protocol Review, Data Analysis, Technical Writing, Microsoft Office, Process Improvement, Mentoring, Budgeting, Planning, Organization, Communication, Analytical Skills

Industry

Research Services

Description

Description Texas Biomed is growing our QA/QC leadership team with a Quality Compliance Senior Manager. This position will manage the Internal Process Quality Control Program working with Study Compliance Manager, Study Directors, and Principal Investigators to ensure that the conduct of all Animal Rule, Good Laboratory Practices, and other studies is consistent with the approved study plan and applicable Standard Operating Procedures and any amendments or revisions thereof. THE ROLE: • Ensure that the Quality Control team adheres to the study schedules established by the Program Management Office. • Provide regular updates to the PMO to confirm that studies are being QC’d as scheduled. • Ensure that the Gantt charts and Study Trackers are updated accordingly. • Manage, supervise, and lead the day-to-day activities of assigned employees. • Plan work schedules, assign tasks, coordinate workload, and provide priorities. • Assist leaders in identifying opportunities to streamline, improve, and/or automate business processes while actively implementing changes as needed. • Manage the Study Compliance Monitor to ensure collaboration with Quality teams, providing timely and accurate assessments of any identified study or protocol deviations. • Advise technical staff in identifying and reporting study deviations. • Work closely with the PI and/or Study Director in the preparation of study plans, amendments, deviation reports and other program related documents for inclusion in the final report and archived study file. • Oversee review of study protocols, amendments, project status reports, final study reports, and other project-related technical documents. • Provide draft protocol reviews to assist Principal Investigators and Study Directors with their protocol development to ensure compliance with applicable regulations (USDA, OLAW/PHS, FDA, and CDC). • Ensure staff perform comprehensive quality review of data and reports for completeness, accuracy, and compliance, and recommend corrective actions to Study Directors/Principal Investigators and/or study staff, as applicable. • Provide guidance in the development of regulatory compliance procedures. OUR IDEAL CANDIDATE: Bachelor’s degree from an accredited college or university. Master’s degree preferred. Five years relevant experience in Quality. RQAP-GLP Certification preferred. Must have excellent supervisory, leadership, and mentoring skills. Ability to implement internal process changes to meet updated requirements. Ability to manage diverse professional teams demonstrate effective management and supervisory skills – communication, organization, planning, budgeting, setting goals and objectives. Ability to direct and train a team across demanding and changing deliverables. Strong commitment to excellence and professional growth for self & others. Specialized skills that may be technical or non-technical, such as research and analytical skills, composing non-routine documents and letters, and ability to use software in complex applications Knowledge and understanding of regulations governing the conduct of nonclinical/preclinical research protocols; medical and scientific terminology. Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. Ability to produce complex documents, perform analysis and maintain databases. WHAT WE CAN OFFER YOU: • Enjoy an employee-centered culture grounded in open communication, empowerment, and trust. We believe in working hard and having fun, offering 100+ culture events each year to bring our team together and keep the energy strong! • Comprehensive health, dental, vision, and life insurance coverage for you and your family—including pet insurance options. • Competitive employer-funded retirement plan with 6% contributions starting on day one, increasing with years of service. • Generous paid time off, including 14 paid holidays and a paid Winter Recess (from the last week of December through New Year’s). • Paid time off for short-term illness and mental wellness, helping you take the time you need when life happens. • Volunteer Time Off (VTO) to encourage giving back to the community. • Paid parental leave to support you and your growing family. • Flexible work arrangements that support a strong work-life balance. • On-site medical clinic, wellness incentives, and prescription support programs designed to make care more accessible and affordable. • On-site fitness center and wellness programs to help you stay active and healthy. • Relaxed dress code so you can feel comfortable and be yourself at work. • Dynamic learning environment with professional development opportunities, mentorship, tuition reimbursement, and leadership programs to support your growth. • Proud recipient of the 2025 Healthy Workplace Platinum Recognition from the San Antonio Business Group on Health (SABGH)—the highest honor for employee-focused wellness initiatives. WHO WE ARE: • Texas Biomedical Research Institute is one of the world's leading independent biomedical research institutions dedicated to advancing global human health through innovative biomedical research. Texas Biomed aims to unravel the mysteries of infectious diseases through innovative thinking, creative problem solving and cutting-edge technologies. • Texas Biomed is the only independent, nonprofit infectious disease research institute in the U.S. to combine: • The highest-level biocontainment labs for infectious disease and biodefense research • A federally-designated National Primate Research Center • More than 80 years of discoveries advancing diagnostics, vaccines and therapies • An entrepreneurial culture and specialized expertise in regulated science required for FDA approval We take pride in fostering a culture of respect, opportunity, and unity. Texas Biomedical Research Institute provides equal employment opportunities for all qualified employees and applicants without regard to race, color, sex, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Responsibilities

Manage the Internal Process Quality Control Program to ensure studies comply with Animal Rule, GLP, and Standard Operating Procedures. Lead and supervise the quality control team while collaborating with Study Directors and Principal Investigators to review protocols and reports.