Director of Quality & Compliance - Pharmaceutical
Work Situation: Remote & ~75% Travel
Location: United States
A mid-size Pharmaceutical Manufacturing company is seeking a Director of Quality and Compliance who will oversee all aspects of quality assurance, regulatory compliance, and continuous improvement initiatives for our 503A and 503B product lines. The ideal candidate will have extensive experience in pharmaceutical quality systems, regulatory requirements, and a proven track record of ensuring compliance with FDA regulations.
The Director of Quality & Compliance will have the following responsibilities...
- Develop, implement, and maintain robust Quality Management Systems (QMS) that comply with FDA regulations and industry standards.
- Ensure the QMS supports the manufacturing, testing, and distribution processes for both 503A and 503B products.
- Conduct regular reviews and audits of the QMS to identify areas for improvement and ensure ongoing compliance.
- Regulatory Compliance:
- Serve as the primary point of contact for regulatory agencies, including the FDA, during inspections, audits, and communications related to 503A and 503B products.
- Lead efforts to obtain and maintain necessary licenses, permits, and certifications required for the production and distribution of compounded medications.
- Develop and oversee QA programs to monitor the quality of raw materials, manufacturing processes, and finished products.
- Provide leadership, guidance, and mentorship to the Quality and Compliance team, fostering a culture of accountability, collaboration, and professional growth.
- Ensure adequate staffing levels, competency development, and training programs to support departmental objectives and organizational goals.
The Director of Quality & Compliance should have the following qualifications...
- Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field required
- Minimum of 10 years of experience in pharmaceutical quality assurance and regulatory compliance, with at least 5 years in a leadership role overseeing 503A and/or 503B products.
- In-depth knowledge of FDA regulations, cGMP guidelines, USP standards, and other relevant industry requirements.
- Proven experience managing FDA inspections, responding to regulatory inquiries, and maintaining compliance in a pharmaceutical manufacturing environment.
- Strong analytical and problem-solving skills, with a demonstrated ability to implement effective quality systems and drive process improvements.
Benefits
- 401k match program
- Remote flexibility
- Dental, Vision, Health Insurance
