Associate Director, Quality

Curia Global Inc. (Albany, NY) seeks an Associate Director, Quality for its Albany, NY location. The position is responsible for helping lead the quality program at the site, constantly bringing new developments in regulations and industry best practices to the Curia quality program. Establish and maintain a risk-based and science-based quality system to protect the public health and to meet Curia’s business needs.

Specifically, the Associate Director, Quality will perform the following duties:

• Establish and maintain a risk-based and science-based quality system to protect the public health and to meet Curia’s business needs;
• Through a quality system approach, ensure compliance in GMP operations, while maintaining an efficient workflow to facilitate the operational excellence;
• Establish and maintain an efficient and compliant validation program including computer software validation and instrument qualification;
• Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development as appropriate. By improving individual performance and group collaboration, the Associate Director will be responsible for improving the overall department productivity and efficiency;
• Provide oversight for the site quality program. This includes ensuring site SOPs are in compliance with corporate standards and procedures, overseeing and assisting with the site training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, and analytical reports;
• Along with the quality associates, be responsible for the release or rejection of GMP testing results. Responsible for oversight of product disposition.
• Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality function;
• Act as the site representative during regulatory agencies and customer inspections;
• Identify and lead operational excellence initiatives, both in the department and site-wide, which result in the overall improvement in both areas;
• Partner with colleagues in other departments to increase the overall effectiveness of the site performance;
• Audit the internal facilities, as well as subcontractors, and outside calibration organizations; and
• Exhibit safety awareness and safe work practices.
  

REQUIREMENTS A Bachelor’s Degree in Chemistry or a related field. Requires 8 years of experience as a chemist in the pharmaceutical or biotechnology industry, which includes 2 years of experience with the following:

• Conducting GMP training, compliance audits, and SOP writing;
• Using Analytical instruments, such as UV-VIS, UPLC, and HPLC; and
• FDA and Good Manufacturing Practice (GMP) regulations.

OR

A Master’s Degree in Chemistry or a related field. Requires 6 years of experience as a chemist in the pharmaceutical or biotechnology industry, which includes 2 years of experience with the following:

• Conducting GMP training, compliance audits, and SOP writing;
• Using Analytical instruments, such as UV-VIS, UPLC, and HPLC; and
• FDA and Good Manufacturing Practice (GMP) regulations.
  

RATE OF PAY: $186,784./year

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.