Director/Senior Director of Quality Control
We invite strong leaders and motivational professionals in the life science industry to join one of the top 10 pharmaceutical companies in the United States, located in the New York City metropolitan area! Within this unique job opportunity in the Quality aspects of the industry you will lead in pharmaceutical development programs, focusing on vaccines and biologics products. This role will allow you to grow and collaborate within the industry as a creative leader waiting to mentor and build their team throughout the business. All employees have the chance to interact internationally thanks to our presence globally, giving them visibility and the chance to directly influence the development of our enterprises.
Responsibilities
- Provide QC oversight by leading, directing, and developing the Quality Control team to ensure high quality bacterial and viral products are safe, potent, and pure. Provides efficient improvements within QC testing and analytics. Display the administrative policies of the company and safety program to your staff and potential candidates when hiring/overseeing the hiring process.
- A positive, interdependent relationship between the QC team and other operating divisions as well as external colleagues must be developed and maintained.
- Oversee all testing of raw materials, packaging materials, and vaccine manufactured products. Continuous development and implementation of Quality Management Systems (QMS) and determining the technical sufficiency of scientific documents and testing methods.
- Develop and maintain standard operating procedures (SOP's) while ensuring compliance within the quality policies of the company.
- Ensuring effective CAPA responses while being responsible for QC audits and inspection readiness.
- Overseeing industry guidelines to ensure their compliance with government regulations such as preparing, auditing, reviewing testing methods, and other good manufacturing practice (GMP) issues.
Requirements
- Degree in life sciences (B.S., M.S., and/or Ph.D.).
- Minimum of 10 years' experience working and leading in Quality Control in the pharmaceutical industry. With at least 5 years in a GMP QC release testing roll.
- Extensive knowledge on regulatory requirements regarding drug substances, biological manufacturing, and release/stability testing.
- Strong demonstration of leadership.
- Specific skills include, but are not limited to, CAPA management, SOP's, FDA regulatory audits, technical writing skills, and Maintaining QMS.
- Oversee hiring provide coaching, and guidance and build a highly innovative QC team.
Salary/Benefits
- Salary Range: $180,000-$240,000
- Benefits: Medical Insurance, Dental Insurance, 401K, etc.
