Senior Vice President, Quality

Senior Vice President, Global Quality – Remote – United States

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 to take the reins from its retiring predecessor. 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.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com

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