Demo

VP GMP Quality

Meet Life Sciences
South San Francisco, CA Full Time
POSTED ON 4/13/2025
AVAILABLE BEFORE 5/12/2025

Job Title: Vice President of Quality

Key Responsibilities:

  • Develop and execute the quality strategy for GMP/GLP functions, ensuring compliance with global regulatory requirements across manufacturing, preclinical, and testing operations.
  • Lead a high-performing team, providing guidance, mentorship, and professional development to support growth and excellence.
  • Serve as the technical subject matter expert for GMP/GLP regulations, overseeing the implementation of quality systems and processes in manufacturing, testing, and analytics.
  • Collaborate with cross-functional teams to integrate quality processes, support CMC and IND document review, and drive continuous improvement in quality standards throughout product development.

Requirements:

  • Bachelor's or advanced degree in Biology, Chemistry, Chemical Engineering, or a related field.
  • At least 15 years of experience in GMP Quality Assurance, with a strong background in small molecule manufacturing and solid oral dosage forms.
  • Proven leadership experience (10 years) in managing teams, fostering collaboration, and driving performance excellence in quality systems.
  • In-depth knowledge of FDA regulations, cGMP, ICH guidance, and global health authority requirements for drug development and commercialization.

Technical Skills:

  • Strong understanding of quality management principles and regulations.
  • Experience with quality system implementations, audits, and inspections.
  • Familiarity with computerized systems, data management, and statistical analysis.

Personal Qualities:

  • Excellent communication, leadership, and interpersonal skills.
  • Able to work in a fast-paced environment with multiple priorities and deadlines.
  • Demonstrated ability to lead by example, foster a culture of innovation, and drive results-oriented decision making.

Work Environment:

  • Collaborative and dynamic work environment with a focus on quality and customer satisfaction.
  • Opportunities for professional growth and development through training, mentoring, and networking.

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