Senior Quality Assurance Supervisor

2 weeks 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 meaningful impact with every product, bringing hope to 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 different stages of development, toxicological assessments, and clinical trials.

Qualifications:

  • Proficient understanding of team dynamics within the organization
  • In-depth knowledge of cGMP, GLP, and FDA regulations
  • Strong communication, organizational, and project management abilities with a knack for managing multiple projects effectively while adapting to changing priorities
  • Highly skilled 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 operations and related Quality systems, including change controls and internal process verification.
  • Collaborate with the training team to ensure compliance with Quality systems among manufacturing staff.
  • 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 as well as clinical product distribution.
  • Review and audit complex documentation, including batch records, GMP protocols, and process validations.
  • 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 best practices and enhancements.
  • Administer, review, 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 to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
  • Act as a QA 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 each year.
  • 11 Company Paid Holidays plus 2 floating holidays annually.
  • 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 program.
  • Tuition Reimbursement and Student Loan Repayment Assistance.
  • Access to Company Paid LinkedIn Learning resources.
  • Employee Assistance Programs available.
  • Flexible work options based on role requirements.

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