Kelly · 22 hours ago
Assistant Director, GMP Internal Audit Program
United States
Full-time
Remote
Director/Executive
$110K/yr - $150K/yr
8+ years expKelly Science & Clinical is seeking an Assistant Director for a GMP Quality Systems opportunity with a biotechnology company in Carlsbad, CA. The role involves leading internal and external audit programs, managing vendor quality systems, and ensuring compliance with regulatory standards to support patient safety and continuous improvement.
OutsourcingProfessional Services
Hiring Manager
Alexandre Neves, Ph.D.
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
Qualification
Required
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
Company
Kelly
We’ve been helping organizations find the people they need longer than any other company in the world.
10001+ employees
H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
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2025 (85)
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2023 (59)
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2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Chris Layden
Chief Executive Officer
N
Nicholas Zuhlke
Vice President, Controller, and Chief Accounting Officer
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