• Build and maintain robust quality program that will effectively support clinical and commercial manufacturing operations;

• Conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved;

• Interpret Regulatory Authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to improve compliance processes and procedures;

• Direct the review and approval of the Quality Manual, Quality Policies, Protocols, SOPS, Batch Records, Test Methods, Raw Material Specifications, and Annual Product Reviews and CAPAs;

• Ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust Change Control system and procedures are developed and maintained to meet worldwide regulatory standards;

• Develop and execute Site QA operating and capital budgets and manage department efforts to control costs within approved levels;

• Provide leadership and managerial oversight to the quality department. Develop staff and work closely with them to ensure that a consistent approach is taken in evaluation and resolution of quality issues.

• BS degree in a scientific discipline (i.e. Chemistry, Microbiology, Chemical Engineering);

• A minimum of 10 years experience in the pharmaceutical industry;

• Good interpersonal and problem solving skills;

• Must have a quality background from the biotechnology/pharmaceutical industry with GMP experience and a successful track record in quality within FDA and/or EMA regulated environment;

• Demonstrated leadership in cross-functional and culturally diverse team settings.