Careers at Pharmasset

• Ensure all work is conducted in accordance with Standard Operating Procedures for quality, safety and cGMPs.
• Provide oversight of clinical manufacturing supply chain, including technical agreements, change control, etc.
• Develop and implement new SOPs and provide quality system and SOP training to internal departments and sites.
• Manage external supplier approval and qualification process from initiation to completion; Plan and execute quality audits for contract laboratories, manufacturers and material suppliers against GMP, ICH, and ISO guidelines in preparation for pre approval inspections (PAI). Requires travel to sites.
• Coordinate site activities and interact with inspectors during regulatory inspections.
• Assist in the preparation for commercialization and scale-up of drug product.
• Assess clinical batch records against approved protocols prior to release.
• Assist with the development and review of QA related documentation including R&D and/or commercial specifications, cleaning validation and analytical method validation protocols and reports, microbiology investigations, equipment/facility qualifications, and quality agreements.
• Approve change controls, batch records, laboratory investigation reports, and deviations and lead product quality investigations, assign corrective and preventive action plans (CAPAs) as applicable.
• Perform related duties, special projects and/or other functions as required.

• Bachelor’s Degree in Chemistry or related discipline with a minimum of 5 years directly related experience in an FDA regulated environment is required; Advanced Degree strongly preferred.
• Scientific knowledge of analytical laboratory research, method validation, process development and computer validation required.
• Prior experience with pre approval inspections is necessary.
• Should possess working knowledge of ICH Quality Systems.
• Knowledge of international cGMP regulations required.
• Candidate must possess effective communication skills and proven ability to interact with internal and external colleagues with diplomacy and tact.
• Must have a systematic, methodical, organized approach with meticulous attention to detail.
• Demonstrated ability to work effectively in a team environment, manage multiple priorities, exercise sound judgment, be well organized, take initiative, be flexible, work well under pressure and produce accurate and timely work.
• Travel up to 30% of time required in order properly to manage the external supplier approval and qualification process.

Pharmasset, Inc. is an Equal Opportunity Employer.