Kelly® Science & Clinical is seeking a Lead Auditor, GMP Quality Systems for a direct hire opportunity with one of our clients, a commercial-stage biotechnology company in Carlsbad, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology industry.
Workplace: Carlsbad, CA or remote (USA)
Position Title: Lead Auditor, GMP Quality Systems
Salary range: 100,000-140,000/ year
Are you ready to help drive innovation at the cutting edge of RNA-targeted medicine and advanced gene technologies? Our client is renowned for pioneering advances in biotechnology, delivering transformative therapies for serious diseases with a growing portfolio of marketed products and an industry-leading pipeline in neurology, cardiology, and other high-impact areas. Financially robust and passionately patient-focused, we are well positioned to continue shaping the future of RNA medicines and gene editing solutions.
We foster a challenging, motivating, and rewarding work environment that champions scientific excellence, creativity, and collaboration. Our culture is fueled by the exceptional talent, dedication, and diverse perspectives of our team. We invest deeply in employee growth and engagement, cultivating lasting partnerships and empowering you to thrive.
Now is the moment to join us as we accelerate our mission to positively impact human health. If you seek meaningful work, a collaborative culture, and the opportunity to advance your career while helping patients in need, we invite you to be a part of our journey.
Position Overview
We’re seeking an accomplished Assistant Director to elevate our client’s GMP Quality Systems and QA Vendor Management programs. This individual contributor role reports to the Director of GxP Quality Systems and is instrumental in leading both internal and external audit programs with an emphasis on computer system validation (CSV) and data integrity audits.
As a key member of our team, you will spearhead vendor management from onboarding and qualification through performance monitoring and compliance assessments. You’ll collaborate with multidisciplinary teams on Change Management, Deviation & CAPA Management, Material Qualification, Quality Agreement oversight, and Risk Management. Your work will directly support our commitment to patient safety, regulatory excellence, and continuous improvement.
Responsibilities

• Lead and execute a comprehensive Internal Audit Program, ensuring organizational compliance and ongoing inspection readiness.
  

• Independently conduct GMP Vendor and Internal audits (onsite, remote, and questionnaire-based), in line with global regulatory requirements and industry best practices.
  

• Oversee the Quality Agreement program: initiate, negotiate, and maintain agreements with GMP vendors, adapting to evolving business and regulatory needs.
  

• Manage Vendor Change Notifications in collaboration with stakeholders, ensuring timely impact assessments and regulatory alignment.
  

• Investigate and analyze vendor quality events, including deviations and CAPA management, tracking trends and ensuring effectiveness.
  

• Maintain alignment with established process lead times, key performance indicators, and quality metrics.
  

• Exhibit strong communication, critical thinking, and technical writing skills to influence and educate both internal and external partners.
  

• Independently manage projects and priorities in a dynamic, fast-paced environment, embracing continuous improvement and regulatory best practice.
  

• Collaborate and lead teams to drive sustained quality enhancements and global compliance.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, or relevant Life Sciences discipline; advanced degrees preferred.
  

• Minimum 8 years’ experience in Life Sciences or Pharma, with deep expertise in Quality Assurance and at least 5 years focused on GMP Vendor Management (advanced degree with commensurate experience considered).
  

• Thorough understanding of domestic and international GMP regulations (FDA, Eudralex, Health Canada, ICH, MHRA, MHLW, etc.).
  

• Demonstrated experience in project leadership, negotiation, problem-solving, and process improvement.

Preferred:

• Knowledge of product formulation and drug delivery device assembly (combination products) and/or antisense oligonucleotide manufacturing.
  

• Proven commitment to quality, overcoming challenges, and driving both corporate and personal success.
  

• Track record of ongoing learning, knowledge sharing, and skills development.
  

• Willingness to travel up to 20% as needed.

This role is primarily based at our client’s headquarters in Carlsbad, CA; remote or hybrid work arrangements may be considered for exceptional candidates.
Join a biotech leader where your skills and ideas can create lasting change for patients and build the future of medicine. Apply today and help us deliver on our promise of scientific innovation and patient impact!
Why Join Us:
Be a vital part of a trailblazing team where your contributions are valued and impactful. Embrace the opportunity to innovate in a collaborative and forward-thinking environment, advancing the future of treatment for neurological disorders.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn’t the perfect match, your profile will remain within our network, ensuring you’re connected to a wealth of future opportunities in the field of science and clinical research.
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