DESCRIPTION:
Oversee and ensure all facets of Quality throughout the company.

SPECIFIC RESPONSIBILITIES:
• Establish and maintain a risk-based and scientific-based quality system.
• Through a quality system approach, ensure all GMP operations are in compliance, while maintain an efficient workflow to facilitate the operational excellence.
• 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 Director will be responsible for improving the overall department productivity and efficiency.
• Oversee, and be ultimately responsible for, the Company’s quality assurance program. This includes overseeing and assisting with the Company’s training and auditing programs, as well as the review of SOPs, investigations, deviations protocols, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records.
• Along with the QA associates, be responsible for the release or rejection of GMP materials.
• Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function.
• Act as company’s representative during regulatory agencies and customer inspections.
• Identify and lead operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.
• Audit the manufacturing and testing facilities of vendors, customers and outside contract organizations. Implement Processes and Systems to assure Sponsor responsibility for regulatory compliance with GMP, GLP and GCP.

QUALIFICATIONS:
Education/Professional Skills & Experience
a. Licenses, certifications and degrees:
(Note: include academic degrees only if absolutely a job requirement.)
Minimum BS degree in Chemistry, Life Science, or related discipline. MS, PhD, MBA preferred, or equivalent experience.

b. Role-related knowledge:
Full understanding of cGMPs, GLPs, and GCPs. Understanding of FDA inspection procedures. Familiarity with pharmaceutical product manufacturing and testing processes.
Experience with Phase I through IV, and in particular, Phase III and experience with Regulatory approval, NDAs and MAAs.

c. Role-related (skills, abilities, behavior necessary to perform the role) including language, mathematical and reasoning (analytical) skills, intellectual, creative and/or communications abilities:
• 10-15 years Quality Assurance experience in regulated industry such as pharmaceuticals, or biologics is required.
• Experience with effectively managing FDA inspections, working with regulators, and customer audits required.
• Experienced at writing manufacturing and laboratory investigations is essential.
• Experience with risk based decision making tools highly preferred.
• Broad knowledge of cGMP, ISO requirements for pharmaceuticals
• Demonstrated ability to manage staff and variable workloads