Attention recruitment agencies:
All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products.
We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases. Company Differentiators: • Fully integrated clinical-phase company with internal manufacturing• Demonstrated ability to move rapidly from idea to IND• Five candidate products in the clinic and two declared pre-clinical programs• Robust technology and IP foundation, including our TVE and manufacturing platforms• Initial product safety and efficacy data substantiates the value of our platforms• Opportunities to expand to other indications and modalities within genetic medicineThe Senior Manager, Quality Document Control, will manage 4DMT's Quality Document Control Program.
Reporting to the Sr. Director of Quality Systems and GCP Compliance, the Senior Manager, Quality Document Control, will be responsible for 4DMT's Quality Document Control Program, which is designed and executed in an efficient, compliant, and inspection-ready manner.This role can be in-person or hybrid. If Hybrid, the role will require regularly scheduled time on-site at 4DMT's Emeryville office at least weekly.
RESPONSIBILITIES:
Quality Document Control Operations / Document Management - 70%
- Perform document control review of 4DMT Policies, SOPs, and Work Instructions and exercise judgment to provide suggestions to align document content and format with 4DMT procedural requirements, standards, templates, and best practices
- Perform document control consistency/quality/formatting checks of all new / revised quality-controlled documents
- Coordinate the 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 that quality-controlled hard-copy/paper files are managed and maintained, including via maintenance of an index, check-in/out procedures, and general security
- Ensure that controlled document-related compliance reporting and inspection readiness support is provided to stakeholders
- Support archival of controlled documents in the EDMS as needed
- Other duties as assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
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:
Education:
- Bachelors Degree a minimum
Experience:
- 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 - $190,000Please 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.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
