Demo

Senior Manager, QA Operations

Meet
Sonoma, CA Full Time
POSTED ON 2/14/2025
AVAILABLE BEFORE 5/11/2025

We are partnered with a growing biotech organization that is seeking a Bay Area-based Senior Manager of QA Operations. This role is focused on providing quality oversight and decision making regarding the starting material and drug substance development and manufacturing at the CDMO. This is a great opportunity for someone who is interested in creating therapeutics for serious autoimmune and cancer indications, which are in clinical trials. This role is ideally seeking candidates who are based in the Bay Area and will work remotely with expected travel.

Responsibilities :

  • Oversee quality-related activities at CDMOs, including cell banking, stability programs, manufacturing, testing, and process development.
  • Manage quality systems at CDMOs, such as deviations, CAPAs, complaints, and batch release, ensuring compliance with standards.
  • Conduct and review quality documentation, including SOPs, batch records, analytical methods, and regulatory submissions.
  • Collaborate with CDMOs and internal teams to address quality issues, ensuring products meet quality standards and specifications.
  • Monitor and report quality metrics, perform risk assessments, and maintain readiness for audits and regulatory inspections.

Requirements :

  • Bachelor’s degree with 10 years or Master’s degree with 7 years of experience in a GMP-regulated biopharma / biotech environment.
  • Expertise in supplier / vendor quality management, biologics quality assurance, and regulatory compliance (FDA, ICH, GMP standards).
  • Proven skills in GMP documentation, risk analysis, project management, and cross-functional collaboration.
  • Strong problem-solving, communication, and organizational abilities, with a focus on adapting to dynamic environments.
  • Preferred skills include root cause analysis, operational excellence qualifications, and availability for up to 25% travel.
  • Contact :

    For a confidential discussion, please reach out to Amit at amit.uma@meetlifesciences.com or 628 336 2772.

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Senior Manager, QA Operations?

    Sign up to receive alerts about other jobs on the Senior Manager, QA Operations career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $166,313 - $206,719
    Income Estimation: 
    $211,831 - $272,127
    Income Estimation: 
    $99,704 - $121,947
    Income Estimation: 
    $124,827 - $154,865
    Income Estimation: 
    $124,827 - $154,865
    Income Estimation: 
    $155,149 - $198,874
    Income Estimation: 
    $122,125 - $158,955
    Income Estimation: 
    $166,313 - $206,719
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Meet

    Meet
    Hired Organization Address Ridgefield, CT Full Time
    Summary : We are seeking a highly experienced Payor Access Specialist to lead the development and execution of market ac...
    Meet
    Hired Organization Address South San Francisco, CA Full Time
    Our cutting-edge client is searching for a Senior Medical Director to join their Clinical Development team! Our client i...
    Meet
    Hired Organization Address San Jose, CA Full Time
    Bioinformatics Analyst On-site / hybrid) The scientific computing team at a biotechnology company is seeking to hire a b...
    Meet
    Hired Organization Address Sunnyvale, CA Full Time
    Director, Market Analytics and Insights - Rare Disease Biotech Meet is currently partnered with an exciting start-up bio...

    Not the job you're looking for? Here are some other Senior Manager, QA Operations jobs in the Sonoma, CA area that may be a better fit.

    QA Operations Specialist

    Tucker Parker Smith Group (TPS Group), Novato, CA

    Senior Clinical Operations Manager

    SiteOne Therapeutics Inc, Sonoma, CA

    AI Assistant is available now!

    Feel free to start your new journey!