Senior Director, IT Compliance & Governance (Contract)

IT Compliance:

• Ensure 4DMT IT meets GxP, SOX & privacy requirements through an auditable control environment & strong evidence management; lead the IT GxP compliance assessment & remediation plan for the upcoming FDA inspection.
• Oversee execution of auditable IT activities-system validation, periodic review, backup/restore testing, change control, SOX ITGC reviews & access/inventory management-by internal teams, managed services, consultants & 3rd party service providers to ensure consistent, on-time, right-first-time execution.
• Serve as a collaborative partner to QA CSV/CSA, Finance Compliance (SOX) & Legal Compliance (Privacy/Transparency) to align & improve governance & compliance policies/SOPs, & execute audit/inspection preparedness activities (e.g., risk-based storyboarding, control/procedure improvements, evidence readiness drills).
• Act as escalation point & examiner-facing interface for IT portions of audits & health authority inspections; explain IT controls & CSV/CSA practices; coordinate IT evidence, storyboards & responses; & manage observations/CAPAs through remediation closure.

IT Council Project Portfolio:

• Own & mature technology portfolio management practices that translate strategy into a clear, funded, executable roadmap with transparent status reporting for leadership decisions; oversee critical implementation programs & drive cross-functional alignment, escalation, dependency management, & delivery discipline.
• Run portfolio intake, prioritization, categorization, risk/value assessment, dependency mapping, benefits tracking & portfolio reporting, with special focus on BLA, Inspection & Commercial Launch programs.

IT Governance:

• Coordinate annual planning & IT Council/steering cadences, IT procurement coordination, & budget development/forecasting & BvA spend tracking.
• Define, implement, & enforce IT governance across verticals through policies, SOPs, & fit-for-purpose processes, establishing ways of working (e.g., project/program governance, IT cadences, KPI/OKR framework) that improve performance & maturity.
• Maintain dotted-line/matrixed governance for IT project managers, IT compliance, IT procurement & system validation staff to drive consistent execution, standard work, & audit/inspection readiness across systems & programs.

• 15+ years of IT GxP (e.g. Part 11) compliance responsibility required
• 12+ years directly managing or auditing IT operational processes
• 10+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5
• 8+ years of experience in a senior IT leadership position w/demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry.
• Direct involvement as IT, compliance, or validation lead for at least one FDA or comparable health authority inspection, including examiner-facing preparation & response
• Recent roles demonstrating expertise managing transparent IT project portfolios that enable effective steering committee oversight & portfolio health monitoring
• Annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties, & SSAE-18 SOC report reviews a plus
• Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead.
• Direct involvement as IT lead or compliance/validation lead in one or more Data Integrity or Computer System Assurance programs
• Experience leading complex, cross-functional technology portfolios or commercial launch programs with dozens of concurrent projects, including roadmap governance, dependency tracking, executive reporting, vendor coordination, & delivery escalation

Education:

• Bachelor’s Degree in a Life Science or Computer Science.
• Certifications related to GxP, SOX & Privacy regulations, IT operations & project management strongly preferred.

Skills:

• Strong knowledge of the IT implications of cGMP, GCP & ICH guidelines, Part 11/Annex 11, Computer System Assurance, Data Integrity guidelines for US, Canada & EU markets, SOX, & privacy/transparency regulations
• Strong skills designing, enabling & auditing compliant IT operational processes, including SDLC, Change, Access, Inventory, Data Protection/Backup, & Service Continuity Management
• Strong skills using & administering GRC, QMS & LMS tools required
• Skills with Smartsheet, SharePoint, Box & Veeva Vault a plus.
• Collaborative Communication Skills:
• Ability to work with a diverse group of personalities & individuals at all levels
• Excellent document authoring, review & writing skills
• Strong verbal communication skills
• Ability to work independently, multitask, and maintain strong attention to detail & accuracy
• Proven ability to set schedules & meet deadlines

Physical Requirements and Working Conditions:

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Hourly compensation range: $122.00 - 136.00/hr

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

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery, Reporting to the Sr. VP, IT & Facilities, the IT Compliance & Governance Consultant is a senior IT leader with two mission-critical objectives: as IT’s examiner-facing leader, ensure FDA inspection success by leading IT GxP compliance assessments, remediation plans, evidence readiness, & inspection response; and drive successful delivery of the IT Council-governed technology portfolio, which includes dozens of critical BLA, Inspection & Commercial Launch-readiness projects.

The role covers three core areas: IT compliance, primarily GxP & SOX; the IT Council project portfolio, including prioritization, status reporting, dependency management, & escalation, with special focus on BLA, Inspection & Commercial launch programs; and IT governance, including IT Council coordination, IT procurement, budget planning/forecasting, policies, SOPs, & cross-functional ways of working., 4DMT is a gene therapy company with a transformative discovery platform –Therapeutic Vector Evolution –that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.

While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.

At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.

4D Purpose Statement: Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients

GUIDING PRINCIPLES

• Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
• Break Boundaries - Question the status quo and innovate beyond conventional approaches
• Beyond Yourself - It’s about patients, their families, our team, our families. We strengthen each other.
• Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans

We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development.