Director, Verification Programs
Function of the Position:
Responsible for the day to day operational leadership of the Manufacturing and Quality Control document and test results review process. Coordinates extensively between the documents review performed at USP India and other USP international sites. Interacts with the lead GMP auditor and laboratory staff both at USP headquarters and USP international sites. Interacts with other USP staff, e.g., DSD directors and scientific liaisons for monograph development and for support activities to help assure a smooth flow of all processes.
•Serves as a spokesperson for USP verification programs – meets with potential customers, gives presentations at conferences, workshops, healthcare exhibits, and seminars
•Performs extensive reviews of manufacturing and quality control documents and analytical results and GMP audits reports as necessary in addition to supervising the team that does the review and laboratory testing.
•Prepares the final disposition report incorporating the observations of the documents review and GMP audit reports.
•Responsible for ensuring all the Standard Operating Procedures pertaining to the Verification program are current and update them as and when called for.
•Provides input to the management regarding the development of new products, programs, and services.
•Works with the marketing communications team in developing literature for use in promoting products, programs and services.
•Periodically , meets with current and potential clients, industry associations, etc., to discuss program operations and direction and to obtain recognition of the program.
Ph.D. Degree in Organic chemistry or equivalent professional degree in field of pharmacy, chemistry, biology, or microbiology, with not less than 10 years of broad analytical laboratory and compendial or regulatory experience or equivalent professional development required.
Knowledge, Skills, Abilities:
Must have pharmaceutical industry experience or multi-year interaction and broad contacts within the industry. Experience in the quality control/quality assurance or Research & Development of processes for fine chemicals will be preferred Strong organizational skills along with excellent written and oral communications ability with a proven track record in publications and presentations. Demonstrated ability to analyze data and make sound scientific decisions. Knowledge and experience in the following areas are desirable: knowledge of good manufacturing practices, FDA’s regulatory requirements for pharmaceutical ingredients, quality control requirements pertaining to pharmaceutical ingredients, stability programs, regulatory aspects of and analytical methodology relating to pharmaceutical ingredients. Thorough knowledge of pertinent regulations, guidelines, and guidance will be desirable
Sales & marketing staff, quality assurance staff, laboratory personnel, legal staff, consultants involved in various aspects of the program, other USP staff and customers participating in the Verification programs
GMP Auditor, Verification Scientists