MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Manager/Sr. Manager, Quality Assurance - Drug Product is responsible for managing and leading QA activities related to drug product, and clinical trial material release. This will include coordinating and communicating with the fill-finish and packaging and labeling Contract Manufacturing Organizations (CMOs) to address quality issues and with the Qualified Person to ensure timely release of Investigation Medicinal Products (IMP). The individual will drive resolution to related issues and concerns, and communicate with supply chain, regulatory and to Sr. Management on a routine basis. This position will also supervise, coach and mentor direct reports.
• Ensure that all master and executed fill finish and packaging batch records are reviewed for accuracy and completeness.
• Review quality control release data associated with the filled and/or packaged lot.
• Provide comments, identifies any concerns, and makes recommendations as appropriate on deviation investigations, non-conforming material reports, change controls or any other quality event records associated with the batch to CMOs.
• Lead the internal cross-functional reviews, communication and follow up with the CMO on the status of open quality event records and ensures their completeness prior to closing the records.
• Review and evaluate temperature excursions associated with storage or shipment of drug product or Investigational
Medicinal Product (IMP).
• Coordinate the reviews and approvals of vial and carton label text for various countries for accuracy and to meet regulatory requirements.
• Identify and communicate quality issues or concerns with drug product and IMP with internal team members to bring awareness and facilitate resolution and elevates to Sr. Management if warranted.
• Perform disposition of drug product lots and packaged and labeled clinical trial material.
• Perform external audits and qualification of CMOs utilized for fill finish and packaging and labeling operations; Write audit reports and send to CMO and follows up on any corrective and/or preventive actions.
• Provide required documentation to the Qualified Person (QP) for obtaining QP declarations and for timely release of IMP into the various European countries.
• Coordinate, lead and manage the internal cross-functional assessments of CMO change notifications and ensures that appropriate responses are provided to CMO as necessary.
• Manage, motivate, and mentor QA Specialists to continuously improve skills and team performance.
Manager, Quality Assurance
• BS Degree in a related field with a minimum of 5 years of experience in quality assurance
Sr. Manager, Quality Assurance
• BS Degree in a related field with a minimum of 7 years of experience in quality assurance
• At least 5 years of experience in a life science GMP regulated manufacturing facility
• Hands-on experience reviewing fill finish and packaging and labeling batch records
• Hands-on experience performing external quality audits
• Hands-on experience writing comprehensive audit reports, and SOPs
• Hands on experience communicating and resolving issues with CMOs
• Prior experience in a commercial environment
• At least two years of direct supervisory experience in Quality
Knowledge, Skills and Abilities
• Demonstrated ability to manage multiple CMO projects at once
• Demonstrated knowledge and understanding of quality systems
• Knowledge of interpreting and applying EU GMP regulations
• Must be very detailed oriented
• Must have excellent interpersonal and people management skills
• Must be able to travel up to 20% globally
• Proficient using MicroSoft Office, specifically with MicroSoft Word, Excel and Powerpoint
One or more QA Specialists
• American Society for Qualification (ASQ) certifications a plus
• Prior experience with Master Control preferred
Executive / senior industry position
Rockville , United States