Global Life Science Hub is partnered with an innovative biopharmaceutical company dedicated to developing novel medicines to address unmet medical needs. With multiple FDA approvals and a focus on various therapeutic areas, including oncology, and infectious diseases, this company has made significant strides in developing small-molecule and biological drug candidates.
As the company transitions into an entire commercial organization, they seek a VP of Quality. The ideal candidate for this critical leadership position will possess extensive experience in the biologics and biosimilars industry, along with a comprehensive understanding of quality management in a manufacturing environment.
Responsibilities: Develop and execute the company's overarching quality strategy, ensuring alignment with global GxP regulations, from drug development through clinical trials to commercialization. Collaborate with the senior management team to integrate quality principles into the organization's strategic goals and decision-making processes. Exercise comprehensive oversight of all QA and QC activities related to biologics manufacturing, encompassing raw material testing, in-process control, and final product release. Maintain a thorough understanding of international regulations and industry standards for biologics manufacturing. Interact with regulatory authorities and oversee inspections to ensure successful approvals and compliance with all relevant regulations. Proactively assess and manage quality-related risks and deviations in the manufacturing process, implementing effective corrective and preventive actions (CAPAs) to mitigate risks and prevent recurrence. Identify opportunities for continuous improvement in quality systems, manufacturing processes, and analytical methods. Implement best practices and lead initiatives to optimize efficiency and product quality. Collaborate with external vendors and Contract Manufacturing Organizations (CMOs) to ensure their compliance with quality standards and contractual agreements. Recruit, develop, and mentor a high-performing team of quality professionals. Foster a culture of excellence, teamwork, and commitment to quality throughout the QA and QC departments. Work closely with other departments, such as R&D, Regulatory Affairs, and Manufacturing, to ensure seamless integration of quality activities across the organization. Qualifications: Bachelor's degree in a relevant scientific discipline; advanced degree (Master's or Ph.D.) is preferred. Minimum of 15 years of experience in a quality leadership position Experience within the biologics space is highly preferred. Strong understanding of global GxP regulations and quality compliance requirements. Proven track record of successful interactions with regulatory authorities Previous experience leading and developing high-performing quality teams. Excellent problem-solving skills and the ability to drive process improvements. Apply: The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
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