Open Position
Title: Associate Director/Senior Manager, Biologics QA
Location: Flexible, US
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Role
The Associate Director/Senior Manager of Biologics Quality (QA) will report to the Director, Biologics Quality. They will be part of the Biologics QA team that provides quality oversight for TG Therapeutic’s (TG’s) biologics commercial and clinical development programs. TG is a virtual company with no in-house manufacturing facilities. TG’s biologics products are manufactured by various global Contract Manufacturing Organizations (CMOs). As such, the location of the role is flexible. Some schedule flexibility will be required for the role, with oversight of vendors in various time zones. Some off-hours meetings and work will be required.
Key Responsibilities
––Review and approve controlled documents, including master batch records, analytical methods, specifications, analytical and process validation protocols and final reports
––Review and approve lot-related deviations, CAPAs, and change controls
––Perform lot dispositions per established procedures
––Work with TG Quality Systems and CMC team to ensure quality and technical documentation is delivered to the internal archiving system
––Facilitate new supplier intakes and qualifications as needed
––In collaboration with Quality Systems team, update and maintain Quality agreements with CMOs
––Support inspection preparedness activities within TG and CMOs
––Provide guidance, advice, and support for GMP quality and compliance
––Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.Contribute to development and improvement of TG Quality System as relevant, such as creation and updating of SOPs
––Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs) in support of the
––Travel approximately 10% of time (domestic and international), including visits to CMOs and TG’s offices in MA, NY and NC; the frequency of travel may increase for a short duration in order to meet critical business needs.
Professional Experience/Qualifications
––Minimum of 5 years’ experience in GMP Quality or Manufacturing in biopharma/biologics/ pharmaceutical industry; experience in biologics is required.
––Thorough knowledge of GMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus
––Experience supporting clinical phase through commercial and lifecycle management
––Experience in oversight of contract manufacturing is key
––Excellent attention to detail, organizational and time management skills,
––Must have strong written and oral communication skills
Education
University degree in life sciences or related fields; Post-Graduate work preferred.