... for IT project managers, IT compliance, IT procurement & system validation staff to drive ... roadmap governance, dependency tracking, executive reporting, vendor coordination, & delivery ...
... for IT project managers, IT compliance, IT procurement & system validation staff to drive ... roadmap governance, dependency tracking, executive reporting, vendor coordination, & delivery ...
Senior IT Systems Manager
Washington, DC · On-site
We are seeking a Senior IT Systems Manager to provide on-demand Cybersecurity and IT services to support the National Indian Gaming Commission (NIGC) mission at the NIGC Headquarters in Washington, D.
Senior IT Systems Manager
Washington, DC · On-site
We are seeking a Senior IT Systems Manager to provide on-demand Cybersecurity and IT services to support the National Indian Gaming Commission (NIGC) mission at the NIGC Headquarters in Washington, D.
IT Manager
Meadville, PA · On-site
$84K - $103K/yr
... systems, and ensuring technology investments align with organizational objectives ... Key Essential Duties and Responsibilities * IT Governance: Establishes and maintains IT governance ...
IT Manager
Meadville, PA · On-site
$84K - $103K/yr
... systems, and ensuring technology investments align with organizational objectives ... Key Essential Duties and Responsibilities * IT Governance: Establishes and maintains IT governance ...
IT Manager
$91K - $112K/yr
Oversee IT infrastructure, applications, and support systems across all business units, ensuring ... Maintain a robust IT governance framework to ensure compliance across all subsidiaries. * Ensure ...
IT Manager
$91K - $112K/yr
Oversee IT infrastructure, applications, and support systems across all business units, ensuring ... Maintain a robust IT governance framework to ensure compliance across all subsidiaries. * Ensure ...
Our expertise enhances health systems and delivers measurable outcomes, helping agencies achieve ... The successful candidate will provide hands-on expertise in IT portfolio governance, project and ...
Our expertise enhances health systems and delivers measurable outcomes, helping agencies achieve ... The successful candidate will provide hands-on expertise in IT portfolio governance, project and ...
Technology Compliance Program Manager, IT Governance & Planning, IS&T
Sunnyvale, CA · On-site
$175K - $263K/yr
Technology Compliance Program Manager, IT Governance & Planning, IS&T Sunnyvale, California, United ... Strong knowledge of, and prior experience with, common controls in: cloud platforms, systems ...
Technology Compliance Program Manager, IT Governance & Planning, IS&T
Sunnyvale, CA · On-site
$175K - $263K/yr
Technology Compliance Program Manager, IT Governance & Planning, IS&T Sunnyvale, California, United ... Strong knowledge of, and prior experience with, common controls in: cloud platforms, systems ...
IT Governance Director, Data & AI Policy
Newark, NJ · On-site
$75 - $80/hr
Strong stakeholder management and executive communication skills. * Ability to drive enterprise ... AI Governance or Responsible AI experience. * IT Governance experience. * Data Operations, Data ...
IT Governance Director, Data & AI Policy
Newark, NJ · On-site
$75 - $80/hr
Strong stakeholder management and executive communication skills. * Ability to drive enterprise ... AI Governance or Responsible AI experience. * IT Governance experience. * Data Operations, Data ...
$175K - $263K/yr
Technology Compliance Program Manager, IT Governance & Planning, IS&T Sunnyvale, California, United ... Strong knowledge of, and prior experience with, common controls in: cloud platforms, systems ...
$175K - $263K/yr
Technology Compliance Program Manager, IT Governance & Planning, IS&T Sunnyvale, California, United ... Strong knowledge of, and prior experience with, common controls in: cloud platforms, systems ...
Senior IT Auditor
Miami, FL · On-site
$89K - $118K/yr
... governance, and service management. * Ability to recommend and implement control measures and ... Contributes to and executes activities throughout the full system development life cycle, including ...
Quick apply
Senior IT Auditor
Miami, FL · On-site
$89K - $118K/yr
... governance, and service management. * Ability to recommend and implement control measures and ... Contributes to and executes activities throughout the full system development life cycle, including ...
1000000550.IT MANAGER II.INFO TECH - APPLICATIONS
Dallas, TX · On-site
$9.2K - $11K/mo
Implement and enforce IT governance policies, cybersecurity best practices, and compliance measures ... Monitors system health, tracks performance indicators, and drives proactive maintenance efforts.
1000000550.IT MANAGER II.INFO TECH - APPLICATIONS
Dallas, TX · On-site
$9.2K - $11K/mo
Implement and enforce IT governance policies, cybersecurity best practices, and compliance measures ... Monitors system health, tracks performance indicators, and drives proactive maintenance efforts.
... manage, and optimize information and business processes. IT Services spans a wide range of ... Qualifications * Bachelor's degree in Information Systems, Cybersecurity, Computer Science ...
... manage, and optimize information and business processes. IT Services spans a wide range of ... Qualifications * Bachelor's degree in Information Systems, Cybersecurity, Computer Science ...
Your expertise will directly influence the development of the FBI's enterprise systems, helping to protect national security through improved data management and IT governance. Key Responsibilities
Your expertise will directly influence the development of the FBI's enterprise systems, helping to protect national security through improved data management and IT governance. Key Responsibilities
Senior Manager, Corporate IT
Cleveland, OH · On-site +1
$127K - $127K/yr
... governance across business systems driven by control requirements and risk decisions defined by ... Vendor management, software licensing, renewals, and Corporate IT budget/spend across the corporate ...
Senior Manager, Corporate IT
Cleveland, OH · On-site +1
$127K - $127K/yr
... governance across business systems driven by control requirements and risk decisions defined by ... Vendor management, software licensing, renewals, and Corporate IT budget/spend across the corporate ...
Senior Business Systems Analyst
Arlington, VA · On-site
$140K - $150K/yr
Your expertise will directly influence the development of the FBI's enterprise systems, helping to protect national security through improved data management and IT governance. Key Responsibilities
Senior Business Systems Analyst
Arlington, VA · On-site
$140K - $150K/yr
Your expertise will directly influence the development of the FBI's enterprise systems, helping to protect national security through improved data management and IT governance. Key Responsibilities
Information Technology, Full Time Pay Grade: 29S Context of Job: IT Governance & Client Success is ... Installs and manages server(s), always ensuring security. Performs system maintenance, configures ...
Information Technology, Full Time Pay Grade: 29S Context of Job: IT Governance & Client Success is ... Installs and manages server(s), always ensuring security. Performs system maintenance, configures ...
$73K - $132K/yr
Ensure accurate information is maintained within approved systems of record. * Coordinate ... Experience supporting IT governance, PMO, IT service management, program management, or performance ...
New
$73K - $132K/yr
Ensure accurate information is maintained within approved systems of record. * Coordinate ... Experience supporting IT governance, PMO, IT service management, program management, or performance ...
New
Sedron is a leading provider of circular waste management technologies for agricultural manure and ... Establish and enforce IT governance policies, standards, and procedures across the organization
Sedron is a leading provider of circular waste management technologies for agricultural manure and ... Establish and enforce IT governance policies, standards, and procedures across the organization
Sedron is a leading provider of circular waste management technologies for agricultural manure and ... Establish and enforce IT governance policies, standards, and procedures across the organization
Sedron is a leading provider of circular waste management technologies for agricultural manure and ... Establish and enforce IT governance policies, standards, and procedures across the organization
This executive oversees enterprise IT governance, portfolio management, Clinical Informatics, and ... Multi-facility healthcare systems * Rehabilitation, behavioral health, post-acute, or specialty ...
Quick apply
This executive oversees enterprise IT governance, portfolio management, Clinical Informatics, and ... Multi-facility healthcare systems * Rehabilitation, behavioral health, post-acute, or specialty ...
Manager, Information Security & Technology
Seattle, WA · On-site
$135K - $169K/yr
... governance. Success in this role depends on a combination of strategic planning and technical ... Network & Systems * Own office and laboratory network security and architecture. * Assess, design ...
Manager, Information Security & Technology
Seattle, WA · On-site
$135K - $169K/yr
... governance. Success in this role depends on a combination of strategic planning and technical ... Network & Systems * Own office and laboratory network security and architecture. * Assess, design ...
It Governance Systems Manager information
See salary details
$46K - $55.7K
5% of jobs
$55.7K - $65.5K
6% of jobs
$65.5K - $75.2K
12% of jobs
$76.6K is the 25th percentile. Wages below this are outliers.
$75.2K - $84.9K
11% of jobs
$84.9K - $94.6K
12% of jobs
The median wage is $98.2K / yr.
$94.6K - $104.4K
12% of jobs
$104.4K - $114.1K
11% of jobs
$121.1K is the 75th percentile. Wages above this are outliers.
$114.1K - $123.8K
10% of jobs
$123.8K - $133.5K
9% of jobs
$133.5K - $143.3K
10% of jobs
$143.3K - $153K
4% of jobs
$46K
$102.1K
$153K
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Senior Director, IT Compliance & Governance (Contract)
Remote
Full-time
Posted 25 days ago
Job description
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
GENERAL SUMMARY:
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.
RESPONSIBILITIES:
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.
QUALIFICATIONS:
Experience:
- 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 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
About 4D Molecular Therapeutics
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1 - 10 Employees
Headquarters location
Emeryville, CA, US
Year founded
2013