Sr Director of Quality Management and Audits
Location: Florida
Work Situation: Onsite
The Sr Director of Quality Management and Auditing will be responsible for overseeing the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with FDA (Food and Drug Administration), CBER (Center for Biologics Evaluation and Research), and CDER (Center for Drug Evaluation and Research) regulations and guidelines. This individual will lead a team of quality professionals to establish and maintain robust quality systems and processes across the organization.
The Sr Director of Quality Management and Auditing will be responsible for
- Develop and implement strategies to establish and maintain a comprehensive Quality Management System (QMS) that meets FDA, CBER, and CDER requirements.
- Provide leadership and direction to the quality team to ensure adherence to quality standards and compliance with regulatory requirements.
- Conduct regular audits and assessments of the QMS to identify areas for improvement and ensure ongoing compliance with FDA, CBER, and CDER regulations.
- Oversee the planning, execution, and follow-up of internal and external audits, including vendor audits, to assess compliance with applicable regulations and standards.
- Collaborate with cross-functional teams to drive continuous improvement initiatives and address quality issues in a timely manner.
- Stay abreast of changes in FDA, CBER, and CDER regulations and guidelines and ensure that the QMS is updated accordingly.
- Provide guidance and support to departments across the organization on quality-related matters, including document control, training, and CAPA (Corrective and Preventive Action) processes.
- Serve as a subject matter expert on quality management and regulatory compliance during regulatory inspections and audits.
The Sr Director of Quality Management and Auditing should have the following qualifications
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance and regulatory compliance in the pharmaceutical or biotech industry.
- Extensive knowledge of FDA, CBER, and CDER regulations and guidelines pertaining to drug and biologics manufacturing.
- Proven experience in developing, implementing, and maintaining Quality Management Systems (QMS) in accordance with regulatory requirements.
- Strong leadership and management skills, with the ability to lead a team and drive results in a fast-paced environment.
- Certification in quality management (e.g., ASQ Certified Quality Manager) or auditing (e.g., ASQ Certified Quality Auditor) preferred.
- Experience leading regulatory inspections and audits is highly desirable.
Benefits
- Competitive Salary
- Health, Dental and Vision Insurance
- 401k match
- Competitive PTO package
If you are interested in the Sr Director of QMS/ Auditing, don't hesitate to apply.