Quality Assurance Manager

Summit Therapeutics, Inc.; Menlo Park (CA); On-site; USD 118,000 - 139,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Manager to ensure compliance with GMP standards in drug manufacturing. This pivotal role involves supporting inspection readiness, conducting root cause analyses, and collaborating with cross-functional teams to enhance quality systems. Candidates should possess a strong background in the pharmaceutical or biotechnology sectors, with at least 5 years of relevant experience. If you are detail-oriented and thrive in a fast-paced environment, this opportunity to contribute to quality assurance initiatives is perfect for you.

Qualifications

• 5+ years of experience in pharmaceutical or biotechnology industry.
• Strong understanding of GMP requirements for biologics manufacturing.

Responsibilities

• Support development and maintenance of GMP quality systems.
• Assist in tracking quality metrics and performance indicators.

Skills

GMP compliance

Quality Assurance

Analytical laboratory testing

e-QMS systems

Problem-solving

Communication

Education

Bachelor’s degree in chemistry, biochemistry, life sciences, or biotechnology

Tools

MasterControl

TrackWise

Job description

THIS POSITION WILL BE ON-SITE IN ONE OF THE FOLLOWING LOCATIONS: San Francisco Bay Area / Miami, FL / Princeton, NJ

Overview Of Role

The Manager, Quality Assurance will report to Quality Assurance leadership and support GMP compliance related to drug substance and drug product manufacturing processes. This role will contribute to quality assurance activities, ensuring compliance with applicable regulations and industry standards. The Manager will assist in inspection readiness efforts, support batch review and release processes, and work cross-functionally to maintain and improve quality systems.

Role And Responsibilities

• Support the development, implementation, and maintenance of GMP quality systems, including policies, procedures, and risk assessments in alignment with global health authority regulations (FDA, EMA, ICH, etc.)
• Assist in ensuring GMP compliance at Contract Manufacturing Organizations (CMOs) by providing sponsor oversight and supporting clinical and commercial manufacturing activities
• Participate in inspection readiness activities, including documentation preparation and coordination for internal audits and regulatory inspections
• Assist with investigations, root cause analysis, risk assessments, and corrective and preventive actions (CAPAs) to ensure timely resolution of quality-related issues
• Support internal QA batch review and release processes to ensure compliance with applicable regulations
• Review and help maintain controlled documents, including Standard Operating Procedures (SOPs), to align with regulatory requirements and industry best practices
• Collaborate with cross-functional teams to achieve quality and compliance objectives
• Assist in tracking and maintaining quality metrics and performance indicators
• Perform other duties as assigned to support Quality Assurance initiatives
• All other duties as assigned
  
  

Experience, Education And Specialized Knowledge And Skills

• Bachelor’s degree in chemistry, biochemistry, life sciences, biotechnology, or a related field
• Minimum of 5+ years of relevant experience in the pharmaceutical or biotechnology industry, with a focus on GMP manufacturing
• Experience with biologics essential; familiarity with analytical laboratory testing is a plus
• Experience working with e-QMS systems (e.g., MasterControl, TrackWise) to execute quality processes
• Understanding of GMP requirements for clinical and commercial biologics manufacturing
• Experience supporting audits and regulatory inspections is a plus
• Strong organizational skills with the ability to handle multiple projects in a fast-paced environment
• Excellent attention to detail, problem-solving abilities, and a strong sense of work ethic
• Effective communication and collaboration skills, with the ability to work cross-functionally
• Fluency in Mandarin is a plus
  
  

The pay range for this role is $118,000-$139,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [e-mail] to obtain prior written authorization before referring any candidates to Summit.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Strategy/Planning and Information Technology

Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x

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