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Associate Director of Quality Assurance

2 months ago

Menlo Park, California, United States CSBio Full time
{"title": "Quality Assurance Director", "subtitle": "Lead Quality Assurance at CSBio", "content": "

CSBio is a leading contract manufacturing company specializing in peptide production. Our commitment to quality and regulatory compliance has earned us a reputation as a trusted partner for pharmaceutical and biotechnology companies.

As a Quality Assurance Director at CSBio, you will be responsible for overseeing our Quality Management System, ensuring compliance with GMP regulations, and driving continuous improvement in our processes.

Key Responsibilities:

  • Host and respond to client audits and regulatory inspections.
  • Oversee Quality Management System, including quality investigations, document control, training, and customer complaints.
  • Develop and implement quality strategies, including risk assessments and gap analyses.
  • Review and approve quality-related documents, including SOPs and deviation reports.
  • Collaborate with cross-functional teams to ensure quality and compliance requirements are met.

Requirements:

  • Bachelor's Degree in Engineering, Life Sciences, Chemistry, or related field.
  • 8+ years of experience in Quality Assurance, with at least 4 years of managing validation and quality systems.
  • Strong GMP knowledge and understanding of ICH and FDA regulations.
  • Ability to work effectively in a fast-paced environment and collaborate with cross-functional teams.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
", "benefits": "
  • Medical, dental, and vision insurance.
  • Basic life insurance and supplemental life insurance.
  • Disability insurance.
  • 401k plan with 10% match.
  • PTO policy.
  • Companywide paid holidays.
  • Carpool, clean air vehicle, and cell phone reimbursement.
  • Employee rewards and recognition program.
  • Company organized social events.
  • Quarterly sponsored team building activities.
", "lang_code": "en"}