TomorrowMed Pharma is a pioneering 503B manufacturing facility poised to revolutionize the pharmaceutical compounding industry. Situated in the heart of Research Triangle Park in Raleigh, NC, this brand-new cutting-edge cGMP facility adheres to strict regulatory standards set by the FDA to ensure the safety, efficacy, and quality of all our products. At TomorrowMed Pharma, we are committed to setting new standards in quality, innovation, and patient-centric care. \n
Driven by a passion for healthcare and a commitment to continuous improvement, we are constantly exploring new opportunities for growth and innovation in the compounding industry. With a collaborative and supportive work environment, we empower our employees to thrive and make meaningful contributions to our mission of enhancing patient care through customized medication solutions.\n
Join us in our pursuit of excellence and become a valued member of our team as we continue to lead the way in 503B pharmaceutical manufacturing.\n
The Quality Assurance Manager will oversee and manage all quality assurance activities for TomorrowMed Pharma. This individual will be responsible for ensuring compliance with FDA regulations, cGMP (current Good Manufacturing Practices), and internal policies and procedures. The Quality Assurance Manager will play a critical role in maintaining the highest standards of product quality and safety while fostering a culture of continuous improvement.\n
Regulatory Compliance:\n\nEnsure the facility's compliance with FDA regulations, including 21 CFR Part 210, 211, and 503B.\nDevelop, implement, and monitor quality systems and procedures to comply with cGMP requirements.\nPrepare for and manage FDA inspections, including responding to Form 483 observations and Warning Letters.\nMaintain up-to-date knowledge of regulatory changes and ensure that the facility remains compliant.\nDevelop and maintain relationships with regulatory bodies and agencies to ensure compliance with regulations.\n\n
Quality Systems Management:\n\nOversee the development, implementation, and maintenance of the Quality Management System (QMS).\nLead investigations into product quality issues, deviations, CAPAs (Corrective and Preventive Actions), and customer complaints.\nConduct regular audits and inspections to ensure compliance with quality standards and identify areas for improvement.\nManage the document control system, including the review and approval of SOPs, batch records, and validation protocols.\n\n
Product Release:\n\nSupervise the batch release process, ensuring that all products meet quality specifications before distribution.\nReview and approve batch records, certificates of analysis, and other documentation required for product release.\nEnsure that all testing, including in-process, release, and stability testing, is performed in compliance with established standards.\n\n
Team Leadership:\n\nLead, mentor, and develop the Quality Assurance team, providing guidance on quality principles and practices and monitoring performance.\nLead and assist with hiring and interviewing of new Quality Assurance employees.\nProvide coaching and counseling to Quality Assurance personnel.\nFoster a culture of quality and continuous improvement throughout the organization.\nDevelop training programs and ensure that all staff members are adequately trained in quality and regulatory requirements.\n\n
Continuous Improvement:\n\nIdentify areas for process improvements and lead initiatives to enhance product quality, efficiency, and compliance.\nCollaborate with cross-functional teams, including Production, R&D, and Supply Chain, to drive quality improvements and operational excellence.\nImplement risk management strategies to proactively identify and mitigate potential quality issues.\nLead and facilitate internal and external quality audits.\n\n
Qualifications\/Requirements:\n
Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) required.\n
Advanced degree (e.g., MS, PhD) or relevant certifications (e.g., ASQ Certified Quality Auditor, Six Sigma) preferred.\n
Minimum of 7-10 years of experience in Quality Assurance within the pharmaceutical or biotechnology manufacturing industry, with at least 3-5 years in a management role.\n
In-depth knowledge of FDA regulations, cGMP, and 503B outsourcing requirements.\n
Experience with quality systems, regulatory inspections, and product release in a highly regulated environment.\n
Experience with parenteral, formulation, Validation of equipment and processes, aseptic processing, Vial and injectable filling, Auditing (both internal and external), Environmental Monitoring, Running an overall Quality Management System including developing and maintaining the system, Supplier management, Batch record review and release.\n
Location:\n
Facility Located in Raleigh, NC 27560 in the heart of Research Triangle Park\n
Comprehensive benefit package is included!