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- Leadership and Strategy:
- On-the-Floor Support:
- Quality Systems Management:
- Training and Development:
- Regulatory Compliance:
- Data Analysis and Reporting:
- 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.
Director of Quality Assurance - Oklahoma City, United States - Plainsvc
Description
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:
o Collaborate with cross-functional teams to develop and implement quality strategies that align with business objectives.
o Provide real-time guidance and support to ensure adherence to quality standards and compliance with regulatory requirements.
o Conduct regular audits and inspections to identify areas for improvement and ensure continuous process optimization.
o Drive initiatives to streamline quality processes, enhance efficiency, and reduce operational risks.
o Foster a culture of continuous improvement through ongoing education and skill development.
o Stay abreast of industry regulations and ensure that all on-the-floor activities comply with applicable quality standards and regulatory requirements.
o Prepare comprehensive reports for senior management, highlighting areas of success and improvement opportunities.
Qualifications:
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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