Vice President, Quality

Proclinical is seeking a Vice President of Quality for a leading pharmaceutical company located in Redwood City, CA. Hybrid flexibility, must be located in the San Francisco/Bay Area or willing to relocate

Job Responsibilities:

• Lead a team of quality professionals, including objective setting, performance management, coaching, training/mentoring, development, and recruiting.
• Proactively identify issues, concerns or any potential or significant risks to the business and ensure that appropriate preventative actions are in place.
• Drive Quality Assurance decisions, approvals, and guidance. Maintain a strong independent role in that regard.
• Recommend, monitor, and engage in corrective actions for all identified excursions from GxPs and SOPs, along with responsibility for coordinating all activities related to training and education in GxPs.
• Implement an Inspection Readiness program that prepares for US and global inspections by any regulatory authority and interface with regulators. Ensure the company has quality systems to ensure Inspection readiness and successful mock inspections and subsequent PAI.
• Accountable for compliant Health Authority inspections outcome and commitment to meet expected alignment.

Skills and Requirements:

• Master's Degree in a scientific discipline ore equivalent.
• Minimum of 15 years of professional quality experience in a high-performance biotechnology or pharmaceutical setting, including a proven history of supporting GMP, GCP and/or GVP/PVQA activities; ideally with a broad emphasis across corporate quality and GxP implementation. A strong GMP background in DS/DP quality is a plus. A demonstrated track record of progressively responsible leadership roles.
• Prior management of commercial quality systems including change management, risk management, supplier management, deviations/CAPA management review and product complaints.
• Broad and deep regulatory knowledge and good understanding of principles and practices of drug development and the benefits of quality compliance to corporate affairs, research and development, clinical and commercial manufacturing, clinical trial contracting/recruiting, medical affairs, medical safety, and regulatory affairs.
• Strong knowledge with both the US and international regulations and guidance, including GXPs and industry trends.
• Experience of previously building out a global quality organization, including recruitment, objective setting, performance management, coaching, training, and development.
• Prior experience in managing health authority inspections.
• Ability to balance multiple priorities and complex issues using logical, analytical, and efficient processes with a high level of attention to detail and quality of work.
• Ability to develop new business relationships and maintain partnerships with internal and external stakeholders. Additionally, have the ability to provide cross-functional team leadership to maintain alignment and to set and meet collective operational goals.
• Excellent oral and written communication skills and can facilitate/articulate recommendations and critical decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop a strong network across the company with strong technical writing experience are required.
• Ability to travel

If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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