QA Manager/ Sr. QA Manager

4D Molecular Therapeutics, located in Emeryville, CA is a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4D Molecular Therapeutics, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. This is an opportunity to join a rapidly growing dynamic platform biotechnology company with multiple products in development
Reporting to the Director of Quality and Compliance, you will oversee Quality Systems such as Document Control and Training Management, Management Review and QMS Administration, Supplier Oversight including the Audit Program, Quality Agreement Management and Supplier Qualification Management, Nonconformance Investigation management, Change Control, CAPA, and Internal Audits. In addition, you will support oversight of manufacture of API, excipients, and clinical drug products internally and at contract service providers (CSPs). Importantly, you will ensure that Quality Systems are in accordance with cGMPs, regulatory commitments, requirements and internal procedures. This is a hands-on position with significant individual contributions required.

You will have the chance to make your mark in this team, partnering with the Director to strategize for the function and also plan for future hiring.

MAJOR RESPONSIBILITIES:

  • Administer the Supplier Management system including the audit program, supplier qualification process and Quality Agreements for CSPs (i.e. contract manufacturers, contract testing laboratories, and API/Excipient Suppliers).
  • Administer the QMS system including Audit, Change Control, Quality Event, Nonconformance and CAPA Modules.
  • Administer the Document and Training Management systems.
  • Administer quality systems including Management Review Program, Annual Product Quality Review (APR) Program, FAR, and Recall/Product Withdrawal.
  • Support Regulatory Audits and Inspections.
  • Review master batch records, specifications, qualification and validation protocols, reports, and labeling materials.
  • Support analytical and manufacturing deviations and investigations.
  • Author and revise controlled documents.
  • Perform other QA responsibilities to ensure and provide cross functional support to Regulatory, Clinical, Manufacturing, Supply Chain.

KNOWLEDGE AND SKILLS:

  • BS degree required. Advanced degree highly preferred.
  • 8+ years of QA experience from a pharmaceutical GMP environment.
  • 4+ years previous experience with managing direct reports required.
  • Experience with manufacturing clinical and commercial pharmaceutical products required; experience with external/contract service providers highly preferred.
  • Experience with electronic document management and QMS systems required.
  • Excellent negotiation and influencing skills, including comfort operating in a highly collaborative cross-functional team environment.
  • Self-starter who proactively establishes effective working relationships and builds partnerships with other disciplines.
  • Effective communications (verbal and written) and interpersonal skills.
  • Adaptability, flexibility, and resourcefulness to roll-up sleeves and multi-task in a small company, dynamic environment.
  • Successful team player who is also capable of working independently with minimum supervision.
  • Ability to work cooperatively with internal and external groups on multiple projects with minimum supervision.
  • Strong multi-tasker with excellent organizational and prioritization skills.
  • Must be computer literate (MS Office Suite).