Quality Director
Company Summary: A small pharmaceuticals company specializing in small molecules, is currently seeking a driven, motivated, and multi-faceted Quality Director. This role will be located in Rockville, Maryland. The Quality Director will play a critical role in leading their quality management efforts.
The Director will be responsible for:
- Develop, implement, and maintain quality assurance programs to ensure compliance with FDA standards.
- Lead and manage the quality team, providing guidance, support, and mentorship to ensure the highest level of performance.
- Oversee the design and implementation of quality control processes and procedures across all departments.
- Conduct internal audits and assessments to identify areas for improvement and ensure adherence to quality standards.
- Collaborate with cross-functional teams to address quality issues, drive continuous improvement initiatives, and mitigate risks.
- Serve as the primary point of contact for regulatory agencies during inspections and audits.
- Develop and deliver training programs to enhance the quality culture within the organization.
- Act as a champion for quality, promoting awareness and fostering a culture of accountability throughout the company.
The Director should have the following qualifications:
- Bachelor's degree in Chemistry (or related field) with at 12+ years of industry experience.
- Prior experience working with small molecule therapeutics.
- Hands-on expertise with building a QMS from scratch and successfully implementing it.
- Strong understanding of regulatory requirements and quality standards (e.g., cGMP, ICH guidelines).
- Proven leadership skills with the ability to effectively manage teams and drive results.
- Certification in Quality Management (e.g., ASQ Certified Quality Manager) is a plus.
- Experience managing regulatory inspections and audits is highly desirable.
If you see yourself in this Director role and are interested, then please don't wait to apply.
