Director - Quality Operations
- Location: Miami, FL
- Working situation: Remote
- Level: Director
Our client, a successful start-up pharma firm, is working to produce small molecule drug products with multiple products in pipeline from Phase I to Commercialization.
The Director - Quality Operations will help lead the Quality department and oversee all aspects of Quality operations and regulatory interactions. This individual will work to foster a culture of quality and compliance through strong leadership and communication while also ensuring that all floor operations are in adherence with the applicable regulations.
The Director - Quality Operations will:
- Conceptualize, create, and develop all Quality Operations strategy in collaboration with other Quality Assurance groups and Manufacturing.
- Identify, direct, and monitor activities to ensure compliance with FDA, and other State, Federal and International regulatory agencies.
- Develop and execute training and Management briefings at any technical or compliance level required on updates and regulatory requirements.
- Oversee the company quality management system deployment and monitoring including client metrics, effective deviation investigation and effective CAPA.
- Participate in interdepartmental/site leadership and operational excellence initiatives.
- Develop and implement GCP, GDP, and GMP training's to be delivered for the Quality Assurance teams.
The Director - Quality Operations has the following qualifications:
- Bachelor's Degree in Biology, Chemistry, Engineering, or related fields.
- Minimum of 10 years of experience in the pharma, biologics or related industry with a minimum of 5 years in a leadership position.
- Ability to maintain a high degree of accuracy and attention to detail.
- Strong leadership experience not limited to mentoring, project management, and training of QA related personnel.
- Competitive 401K match
- Unlimited PTO
- Flexible remote environment
If you are interested in the role of Quality Operations Director, don't hesitate to apply today!