Sr Director of QMS and Auditing
Company: EPM Scientific - Phaidon International
Location: Miami
Posted on: May 2, 2024
Job Description:
Sr Director of Quality Management and AuditsLocation:
FloridaWork Situation: OnsiteThe 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 packageIf you are interested in the Sr Director
of QMS/ Auditing, don't hesitate to apply!
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Keywords: EPM Scientific - Phaidon International, Key Biscayne , Sr Director of QMS and Auditing, Executive , Miami, Florida
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