Director of Quality Assurance

2 weeks ago

Oklahoma City, United States Wheeler Bio, Inc. Full time
Job DescriptionJob DescriptionDirector of Quality Assurance

Position Overview: We are actively seeking a skilled and experienced Director of Quality Assurance to join our dynamic team. In this role, you will be accountable for the continued development, implementation, and improvement of the Wheeler Bio quality management system to ensure continued compliance with regulatory requirements and industry standards. This role requires a strategic mindset, strong leadership skills, and a keen understanding of quality assurance in the pharma/biotech sector.

Key Responsibilities:
  • Leadership and Strategy:
    • Provide strategic direction for quality assurance activities on the production floor in partnership with Manufacturing Operations.
    • Collaborate with cross-functional teams to develop and implement quality strategies that align with business objectives.
  • On-the-Floor Support:
    • Establish a strong on-the-floor quality presence, actively engaging with production teams to address immediate quality concerns.
    • Provide real-time guidance and support to ensure adherence to quality standards and compliance with regulatory requirements.
    • Conduct regular audits and inspections to identify areas for improvement and ensure continuous process optimization.
  • Quality Systems Management:
    • Oversee the development, implementation, and maintenance of robust quality systems on the production floor.
    • Drive initiatives to streamline quality processes, enhance efficiency, and reduce operational risks.
  • Training and Development:
    • Assure delivery of training programs for production staff to enhance their understanding of quality standards and compliance requirements.
    • Foster a culture of continuous improvement through ongoing education and skill development.
  • Regulatory Compliance:
    • Stay abreast of industry regulations and ensure that all on-the-floor activities comply with applicable quality standards and regulatory requirements.
    • Collaborate with Wheeler Bio leadership to prepare for and respond to regulatory inspections.
  • Data Analysis and Reporting:
    • Utilize data analytics to monitor key quality metrics and trends on the production floor.
    • Prepare comprehensive reports for senior management, highlighting areas of success and improvement opportunities.

Qualifications:
  • Bachelor's or advanced degree in a relevant scientific field.
  • 8-10 years of experience in quality assurance within the biotech or pharmaceutical industry.
  • Proven experience in on-the-floor quality support in a manufacturing setting.
  • Strong knowledge of regulatory requirements and quality standards (e.g., FDA, EMA, TGA).
  • Excellent leadership and communication skills with the ability to influence and inspire teams.
  • Demonstrated success in developing and implementing effective quality systems.


LOCATION:

Wheeler Bio’s headquarters are in Oklahoma City, OK. Because it is expected that this individual will work and operate onsite, he or she will be required to relocate to the Oklahoma City headquarters to lead this expanding team.

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