Senior Quality Assurance Lead

1 week ago

San Francisco, California, United States EPM Scientific - Phaidon International Full time

Quality Assurance Supervisor

This organization is at the forefront of cGMP production and is dedicated to advancing gene therapy solutions. Their mission is to develop innovative, safe, and effective long-term treatments for various diseases by leveraging their extensive expertise, resources, and technological capabilities in translational and regulatory science. As they strive to impact every product positively, they aim to instill hope in patients and their families, regardless of the rarity or complexity of the conditions they address. The core focus of this biotech firm is the comprehensive production of Adeno Associated Viruses (AAV). Annually, they partner with over 100 clients to manufacture AAV across various stages, including development, toxicological assessment, and clinical applications.

Qualifications:

  • Solid understanding of team dynamics within the organization
  • Thorough knowledge of cGMP, GLP, and FDA regulations
  • Exceptional communication, organizational, and project management abilities, with a knack for managing multiple projects and adapting to shifting priorities
  • Proficient in Microsoft Office Suite (PowerPoint, Excel, Word), particularly in data analysis and reporting
  • Capable of working independently as well as collaboratively in a diverse and inclusive environment
  • Client-focused approach in daily responsibilities

Responsibilities:

  • The QA Operations Supervisor is tasked with supporting internal Quality Assurance activities centered on GMP manufacturing processes and related Quality systems, including change control and internal process verification.
  • This role involves collaboration with the training team to ensure compliance among manufacturing staff with Quality systems.
  • Implement Quality systems to facilitate CDMO manufacturing and lot release, GxP auditing, and training initiatives.
  • Provide quality assurance support for both external and internal AAV and Plasmid manufacturing, as well as clinical product distribution.
  • Review and audit complex documentation, including batch records, GMP protocols, and validation processes.
  • Support the Product Disposition of client AAV and Plasmid lots for release.
  • Review and authorize master and executed batch records.
  • Observe manufacturing processes to promote the adoption of best practices and enhancements.
  • Manage, review, and approve internal/external Deviations, Change Records, and Corrective and Preventive Actions (CAPAs).
  • Oversee the Document Management System by authoring, reviewing, and approving Policies, SOPs, and Work Instructions as necessary.
  • Communicate quality metrics, client production tracking, and quality improvement initiatives to senior management.
  • Provide oversight and input for Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
  • Act as a Quality Assurance Subject Matter Expert during client and regulatory audits.
  • Schedule QA-on-the-floor responsibilities for the QA Operations team to support manufacturing activities.
  • Ensure documentation is maintained in accordance with internal protocols and regulatory standards.
  • Foster an environment that encourages communication and teamwork within Quality Assurance and related departments.
  • Exercise discretion, judgment, and personal accountability.

Benefits:

  • Opportunity to collaborate with industry experts with over a decade of experience in gene therapy.
  • Competitive salary package.
  • Immediate eligibility for medical, dental, and vision insurance plans, with basic vision covered at 100% by the company.
  • 160 hours of Paid Time Off annually.
  • 11 Company Paid Holidays plus 2 floating holidays each year.
  • Company Paid Life Insurance.
  • 401(k) Matching program.
  • Company Paid short and long-term disability coverage.
  • 4 weeks of Paid Parental Leave for birth and adoption.
  • Adoption Assistance programs.
  • Tuition Reimbursement and Student Loan Repayment Assistance.
  • Access to Company Paid LinkedIn Learning resources.
  • Employee Assistance Programs available.
  • Flexible work arrangements (role specific).

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