Job: Manager, CMC Quality, Istari Oncology, Morrisville, NC
Istari Oncology, Inc. offers full-time employees the opportunity to participate in an excellent compensation and benefits package including a 401(K) and medical, dental, vision, STD, LTD and life insurance.
Istari Oncology, Inc. is currently seeking a Manager of CMC Quality for immediate hire in our RTP Office, located in Morrisville-Durham, NC. The selected candidate will be responsible for providing oversight for manufacturing, quality control, analytical, auditing, and support activities performed at CMO’s and CRO’s, or internally as appropriate.
-Provide direct Quality oversight for the development and implementation of processes and procedures for manufacturing and testing to ensure identity, quality, purity, and potency of PVSRIPO and other products in the Istari pipeline.
-Responsible for driving efficiencies and supporting the overall manufacturing process including process development activities, drug substance formulation and drug product manufacturing (filling, labeling, packaging, and distribution).
-Ensure that all products manufactured meet the registration and cGMP requirements based on all regulatory requirements.
-Assist in making key quality decisions such as deviations, CAPA’s, change control, and complaint investigations.
-Collaborate with internal and external stakeholders and partners to ensure adherence to quality assurance requirements of cGxP’s and associated industry guidelines as appropriate.
-Implement, manage, and maintain electronic Quality Management System
-Actively improve existing quality systems (investigations, batch records, SOPs, CAPA’s)
-Effectively interact with Manufacturing and other functional business units to maintain cGMP and Regulatory Compliance requirements of production/ processing.
-Serve as the System Administrator for the eQMS to manage system access rights and revision control to ensure security of system and integrity of master documents
-Manage, plan, and maintain standard operating procedures and policies that support company objectives and regulatory requirements
-Drive new ideas and innovation to promote process improvement for manual and electronic documentation systems
-Develop, establish, and maintain quality metrics that measure compliance against document control requirements for reporting up to the most senior levels of management
-Develop presentation materials for upper management to disseminate on the topics of quality issues, QMS and quality initiatives
-Manage the GXP training program to ensure all training is tracked, trended, and monitored
-Manage and prioritize on-going continuous improvement projects directly related to Quality Systems to support business needs
-Manage and maintain deviations, CAPAs, effectiveness checks, vendor qualification/auditing schedules, change control and product complaints
-Provide Quality oversight and support of any Part 11 compliant software solutions procured by Istari. This includes review of system validation documentation (e.g., Implementation Plans, Test scripts, Functional Requirement Specifications, Performance Qualifications, Operation Qualifications)
-B.A. / B.S. required (science degree preferred)
-A minimum of 3 years of experience in biopharmaceutical, pharmaceutical, or biologics based GMP quality operations including direct experience with aseptic fill/finish, testing of drug substance and drug product and laboratory operations. Experience with cell culture, purification, and viral gene therapies is strongly desired.
-Strong knowledge of FDA regulations, ICH guidelines, and Good Manufacturing Practices.
-Experience with interacting with FDA or other Regulatory Agencies in an inspection-based setting.
-Manufacturing Quality or Quality Systems background preferred.
-Travel 15-20% of the time, within US, as needed.