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Senior Quality Assurance Supervisor

2 months 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. Their mission is to develop innovative, safe, and effective long-term treatments for various conditions by leveraging their expertise, resources, technology, and knowledge in translational and regulatory science. They strive to make a significant impact with each product and instill hope in patients and their families, regardless of the rarity or complexity of the condition. 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 of development, toxicological assessments, and clinical applications.

Qualifications:

  • Proficient understanding of team dynamics within the organization
  • In-depth knowledge of cGMP, GLP, and FDA regulations
  • Exceptional communication, organizational, and project management abilities with a proven track record of managing multiple projects effectively while adapting to changing priorities
  • Advanced skills in Microsoft Office Suite (PowerPoint, Excel, Word), including data analysis and reporting
  • Ability to work autonomously as well as collaboratively in a diverse and inclusive environment
  • Client-centric approach in daily responsibilities

Responsibilities:

  • The QA Operations Supervisor is tasked with supporting internal Quality Assurance functions that emphasize GMP manufacturing operations and related Quality systems, including change controls and internal process verification.
  • This role involves collaborating 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 support for both external and internal AAV and Plasmid manufacturing and clinical product distribution.
  • Review and audit complex documentation, including batch records, GMP protocols, and validation processes.
  • Fully support the Product Disposition of client AAV and Plasmid lots for release.
  • Review and approve master and executed batch records.
  • Observe manufacturing processes to promote the adoption of best practices and enhancements.
  • Administer, review, follow-up, and approve internal/external Deviations, Change Records, and Corrective and Preventive Actions (CAPAs).
  • Manage 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 variations 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 in support of manufacturing activities.
  • Ensure that documentation is maintained in accordance with internal procedures 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 experts with over a decade of experience in the gene therapy sector.
  • Competitive salary package.
  • Eligibility for medical, dental, and vision insurance plans from day one, with basic vision fully covered 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 childbirth and adoption.
  • Adoption Assistance.
  • Tuition Reimbursement and Student Loan Repayment Assistance.
  • Access to Company Paid LinkedIn Learning resources.
  • Employee Assistance Programs.
  • Flexible work arrangements (role-specific).