Director of Quality Control

3 weeks ago

Miami, United States EPM Scientific Full time

Director of QC

Location: Miami, FL Work Situation: Onsite

A mid-size biotech is seeking a highly skilled and experienced Director of Quality Control to lead our Quality Control (QC) department. The Director of Quality Control will be responsible for ensuring the quality and integrity of our biologic products through effective management of QC operations, compliance with regulatory requirements, and implementation of quality control strategies. This role requires strong leadership, strategic thinking, and technical expertise in biologics manufacturing and quality control processes.

The Director of Quality Control will have the following responsibilities... Develop and implement QC strategies, policies, and procedures to ensure the quality and compliance of biologic products throughout the manufacturing process. Provide leadership and direction to the QC team, including hiring, training, and performance management of QC staff. Oversee all aspects of QC testing, including raw materials, in-process samples, finished products, stability studies, and environmental monitoring. Establish and maintain robust QC systems, including equipment qualification, method validation, and documentation practices, in accordance with regulatory standards (e.g., FDA, EMA, ICH). Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory Affairs, and R&D, to support product development, process improvements, and regulatory submissions. Ensure timely release of biologic products by conducting thorough review and approval of QC data, investigations, and deviations. Oversee endotoxin testing, total organic carbon (TOC) analysis, sterility testing, and other relevant analytical assays to ensure compliance with regulatory requirements and internal quality standards. Manage the daily operations of the Quality Control laboratory, including scheduling, resource allocation, and workflow optimization, to ensure efficient and timely testing of biologic products. Act as a subject matter expert on QC-related matters during regulatory inspections, audits, and interactions with regulatory agencies.

The Director of Quality Control should have the following qualifications... Master's degree in Biochemistry, Biotechnology, Microbiology, or related field; advanced degree (e.g., Master's required or PhD preferred). Minimum of 10-15 years of progressive experience in quality control within the biotech or pharmaceutical industry, with at least 8 years in a leadership role. Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques. Strong knowledge of regulatory requirements for biologics, including cGMP, ICH guidelines, and relevant pharmacopeial standards. Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections. Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external stakeholders. Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously. Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities and deadlines.

If you are interested in the role of Director of QC, please don't hesitate to apply

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