Director, Regulatory Compliance - GLP/QA
The Director provides leadership for Regulatory Compliance at Texas Biomedical Research Institute, with primary oversight of the Quality Assurance Unit and a focus on working with other key individuals in the organization to enhance and sustain a GLP program. Liaises are between Test Facility Management and key leads in QA and QC, Study Directors, and associated support personnel. This individual will manage all aspects of quality across GLP and quality systems. Duties and responsibilities include:
- Develops, implements and maintains the Quality Assurance program
- Leads process improvement and harmonization efforts that promote best practices
- Accountable for budgetary planning and cost control for their assigned areas of responsibility
- Works with other management personnel to establish company policies and operating procedures
- Develops initial and subsequent changes of the Quality Assurance program to determine areas of responsibility, personnel requirements and operational procedures
- Oversees initiatives on GLP and compliance including the conduct of audits, inspections of GLP studies, and equipment qualification and computerized system validation projects
- Provides quality expertise, advice and/or assistance across the organization as required
- Leads efforts and collaborates with internal and external partners to ensure readiness of all GLP activities associated with regulatory filings, this includes assisting in site preparations for support of regulatory inspections
- Works with the company’s Senior Management to identify, evaluate, and recommend solutions to issues identified during the performance of internal audits
- Hires, and trains employees; plans, assigns and directs work; conducts performance appraisals, rewards and disciplines staff; addresses complaints and resolves issues
- Identifies procedural and process issues and oversees implementation of necessary corrective actions and continuous improvement activities. Contributes to the evaluation and mitigation of program risks and escalation of potentially significant quality issues
- Manages the internal facility inspection program and audits of subcontractors utilized on GLP studies
- Acts as regulatory escort and client audit escort and facilitator. Follows up on regulatory and client audit findings to ensure compliance
- Collaborates with Information Technology or other departments, as necessary, to identify, evaluate, and recommend solutions to issues identified in the performance of validation audits
- Ensures internal and external training of the company’s staff and vendors as required. Provides GLP and other applicable regulatory training for staff through seminars and distribution of materials
- Prepares clear and concise written reports of audit observations, including an assessment of compliance. Assesses adequacy of action plan. Conducts follow up activities as needed to monitor corrective actions. Collects data from internal/external audits and reports metrics and trends in order to implement process improvements
- Performs other duties as assigned.
EDUCATION/EXPERIENCE/SKILLS: Requires a Bachelor’s Degree from an accredited four-year college or university. The required major is scientific or life science field. Experience: Requires a minimum of ten years of experience. Experience should be in a pharmaceutical industry and/or contract research organization in GLP quality assurance of which 2 or more years are in auditing GLP studies. Supervisory experience required. Expert knowledge of GLP requirements required. Excellent interpersonal skills, ability to interact effectively with all levels of personnel within the organization and externally with investigators and study site personnel. Maintains professional expertise and knowledge of local and international regulations, by attending courses and networking with RCO colleagues. Ability to review documents, processes and procedures; identify issues/problem areas; assess compliance; communicate findings to the teams. Strong communication skills (reading, writing, verbal); ability to conduct and review audits; attention to detail; knowledge of medical terminology, toxicology, and validation; ability to interpret and administer a variety of instructions whether in writing or verbal; ability to solve problems and process large amounts of data and information with completeness and accuracy; ability to understand appropriate mathematical and statistical concepts for interpreting scientific data. Preferred: Registered Quality Assurance Professional in GLPs recommended. Demonstrated leadership and project management skills in a quality environment is preferred. Knowledge of Toxicology and Animal Rule auditing desired.
POTENTIAL HAZARDS: Standard clinical, laboratories and/or office environments and mechanical rooms. Exposure to animal biosafety level 2, 3 & 4 (ABSL2/3/4) and a bio safety level 2, 3 & 4 (BSL2/3/4) laboratories. May work with occupational hazards such as infectious diseases and harmful chemicals. Exposure to mechanical and electrical hazards and may be required to work in crawlspaces. Work may involve potential exposure to unpleasant odors, animal wastes, animal tissue and animal body fluids. May work with infectious agents such as herpes B virus, SIV, HIV, STLV, Vaccinia, tuberculosis, and Shigella. May work with toxic chemicals, caustic and acid cleaning and sterilizing compounds. May involve potential exposure to compressed gases, cryogenics, electrical hazards, heat/cold/noise/pressure, radioactive materials, and x-ray equipment. Physical demands may include moderately difficult physical activity that includes prolonged standing and/or walking, handling moderate weight objects and/or using or carrying equipment.
OTHER: This is a full-time salaried (exempt) position. Texas Biomed business hours are Mondays through Fridays – 8:00 a.m. to 5:00 p.m. Texas Biomedical Research Institute is committed to a drug-free workplace. Pre-employment drug screen is required.
Application packets are accepted electronically or in hard copy. A completed application packet is a requirement for all positions. Incomplete applications will not be accepted. Equal Employment Opportunity/M/F/Disability/Protected Veteran Status
Your resume and application must be provided electronically. Please follow the steps below.
- Please read instructions before submitting your application.
- PDF forms will need to be completed, saved to your computer and uploaded. Please refer to Step 2 for additional information.
- Fill out the online form.
- At the conclusion of the application process, you will be asked to attach your PDF files.