Senior Manager, Quality Document Control Specialist

4 weeks ago

Emeryville, California, United States 4D Molecular Therapeutics Full time

Job Summary:

The Senior Manager, Quality Document Control, will oversee 4DMT's Quality Document Control Program, ensuring it is executed in an efficient, compliant, and inspection-ready manner. This role can be in-person or hybrid, with regular on-site time at 4DMT's Emeryville office.

Responsibilities:

  • Quality Document Control Operations / Document Management - 70%
    • Perform document control review of 4DMT Policies, SOPs, and Work Instructions, providing suggestions for alignment with procedural requirements, standards, templates, and best practices.
    • Perform document control consistency/quality/formatting checks of all new/revised quality-controlled documents.
    • Coordinate review, finalization, and obsoletion of select 4DMT policies and procedures with stakeholders.
    • Ensure compliance with Quality Controlled Document procedures through close collaboration with document authors, owners, and reviewers.
    • Coordinate with Quality Training to ensure training requirements are established for new and revised procedures ahead of their release.
    • Provide support during audits and inspections.
    • Ensure quality-controlled hard-copy/paper files are managed and maintained, including via maintenance of an index, check-in/out procedures, and general security.
    • Ensure controlled document-related compliance reporting and inspection readiness support is provided to stakeholders.
    • Support archival of controlled documents in the EDMS as needed.
  • 4DMT's Quality Document Control System/Process Owner - 30%
    • Define/update policies and procedures related to 4DMT's Quality Document Control Program.
    • Work with functional leaders across the business to ensure GXP-controlled document requirements are defined appropriately and implemented within the electronic document management system (EDMS).
    • Provide direction/guidance on EDMS configuration and related processes to IT EDMS system administrators.
    • Ensure the EDMS is configured and administered to manage quality-controlled documents in an efficient, compliant, and inspection-ready manner.
    • Work with interdepartmental subject matter experts at all levels of the organization to plan, develop, and coordinate execution of GXP Controlled Document programs/initiatives.
    • Lead execution of User Acceptance Testing of EDMS features related to quality-controlled documents.
    • Participate in cross-functional project teams to refine controlled document processes.

Qualifications:

  • Bachelor's Degree minimum.
  • 8+ years of experience in biotech/pharmaceutical industry, including in a position leading a controlled document-related program/process.
  • 4+ years of managerial experience.
  • Expert knowledge of GxP concepts and guidelines as they relate to controlled document requirements.
  • Advanced business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industry.
  • Demonstrated ability to manage multiple, highly complex projects concurrently.
  • Prior experience in monitoring adherence to document control programs.
  • Demonstrated ability to influence and negotiate effectively and implement large-scale change.
  • Experience with EDMS platforms used within Life Sciences.
  • Subject matter expert of ACE or Veeva.

Skills:

  • Expert Knowledge of MS Word Document formatting and processing.
  • Excellent written and verbal communication skills.
  • Strong organizational skills.
  • Proficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint), Adobe Acrobat, and survey tools.
  • Knowledge of GCPs, GLPs, and GMPs.

Base salary compensation range: $155,000 - $190,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial, and local laws.

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