Quality Director (Biologics / Aseptic Environment)

Confidential Company  •  Houston, TX and North Brunswick, NJ

11 - 15 years experience  •  Biotech/Pharma

$180K - $204K ($150K - $170K base + 20%)
Posted on 10/20/17 by Lisa Gabor
Confidential Company
Houston, TX
11 - 15 years experience
$180K - $204K
($150K - $170K base + 20%)
Posted on 10/20/17 Lisa Gabor

Director of Quality Assurance



The Director, Quality Assurance is responsible for designing, planning, implementing, directing and evaluating a quality assurance function and a quality management system for regulated activities provided across organization.

The Director will report to the Senior Director, Quality Assurance. The Director will work collaboratively with management and leadership in the evaluation of operations and the provision of services and problem resolution, and will recommend or initiate any necessary changes.



1. Develop, implement, maintain and continually assess a quality assurance function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to the following tasks:

  • Developing a document control system for procedures, work instructions and forms
  • Developing and implementing appropriate quality training
  • Formulating and administering policies and standard operating procedures (SOPs) relating to the quality assurance function and the quality management system
  • Using incident and Corrective and Preventive Action (“CAPA”) activities and processes to drive quality improvements and respond to process and service issues
  • Implementing, performing and overseeing internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities
  • Guiding the development of all quality assurance activities and quality management system processes
  • Ensuring applicable services are “inspection ready”

2. Define, develop and implement short-term and long-term strategies, goals, objectives and tactics relating to the quality assurance function and the quality management system

3. Review and recommend appropriate corrective action to ensure consistency with the quality assurance function and the quality management system

4. Implement a continuous improvement plan for growing and maturing the quality assurance function and the quality management system, including the following tasks:

  • Performing periodic internal quality management system reviews and audits
  • Designing and developing key quality, compliance and performance indicators
  • Designing, developing, implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality assurance function and the quality management system
  • Analyzing performance of quality assurance function and quality management system activities and documented resolutions, identifying problem areas, and devising and delivering solutions to enhance quality control and prevent future issues

5. Keep senior management appraised of quality assurance issues as needed

6. Represent quality assurance function and quality management system and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assist with quality-related information related to (but not limited to) client assessments, RFPs, contracts and other documentation

7. Maintain current knowledge base of regulations, corporate policies and standards to ensure that the quality assurance function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices

8. Perform related duties, as assigned



·        Master’s or Bachelor’s degree, emphasis in scientific or health care discipline preferred.

·        Minimum 10-15+ years of successful quality leadership experience in a pharmaceutical, biotech or medical device environment.

·        Six SigmaBlack Belt (or other nationally-recognized business process improvement certification), highly preferred.

·        Solid knowledge of and experience with working in an Aseptic Environment (Aseptic processes in cleanrooms)

·        Experience working in a very High-Volume Production Environment



  1. Advanced knowledge of content and application of national and global regulatory and consensus standards and practices involving quality, including but not limited to Current Good Clinical Practices (cGCP) / cGMP, Food and Drug Administration (FDA) guidance and regulations, International Conference on Harmonization (ICH) guidance and standards, International Organization for Standardization (ISO) standards
  2. Advanced knowledge of quality management methodologies, processes and systems
  3. Highly self-motivated and self-directed
  4. Strong problem-solving, quantitative, analytical skills
  5. Detail-oriented and excellent organizational skills
  6. Strong leadership skills, including change management
  7. Strong creativity skills
  8. Strong interpersonal and influencing skills
  9. Strong presentation and training skills
  10. Ability to communicate effectively both orally and in writing
  11. Ability to work in a fast-paced team environment and handle multiple projects and tasks
  12. Ability to analyze problems, identify alternative solutions and implement recommendations for resolution of problems
  13. Knowledge of Microsoft Word, Excel and PowerPoint
  14. Willingness and ability to travel

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