Compensation Overview

GENERAL SUMMARY: 

The Associate Director, IT Compliance will report director to the Sr. VP, IT & Facilities. This role is directly responsible for developing, implementing & maintaining 4DMT’s IT compliance program meeting all applicable regulatory requirements including GxP (Part 11), SOX (Sarbanes Oxley Act) & privacy laws (GDPR, CCPA).

RESPONSIBILITIES:

• Ensures 4DMT IT operates in compliance to GxP, SOX & Privacy regulations & ensures compliance objectives are demonstrably met with auditable evidence on an ongoing basis.
• Builds effective partnerships with business process owners, IT system owners, system administrators, Quality staff, internal/external auditors, inspectors & other cross-functional stakeholders to develop, implement & maintain the IT compliance program.
• Develops, manages & maintains compliance strategy, governance, policies, processes, controls, improvements, risk assessments, compliance checks & team domain knowledge to ensure the following key activities are effectively & efficiently executed for 4DMT IT systems:
• System Validation, Periodic Review
• IT Change Management & SDLC
• Data Integrity, Service Continuity & Data Protection/Backup
• System Access & Inventory Management
• IT Incident, Non-Conformance, CAPA Management
• IT Document Control, Training & Curriculum Management
• SOX Risks & Controls Design, Operational Effectiveness & Testing
• IT Supplier Assessment & Service Organization Control (SOC1) Reviews
• Auditor/Inspector Relations & Inspection Management
• Manages IT compliance-related staff, service providers, budgets, audits, inspections & projects.
• Conducts risk assessments of key systems, accounts, & other in scope areas & activities.
• Acts as the primary IT contact for all related compliance audits or inspections, including those related to SOX, GxP & Privacy.
• Provides expert consulting across 4DMT stakeholders of the IT regulatory landscape & upcoming changes, of compliance requirements & best practices & of continuous improvement.
• Develops, socializes & reinforces responsibility matrices to ensure compliance responsibilities are clearly understood throughout 4DMT.

QUALIFICATIONS:

Education:

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

Experience:

• 8+ years directly managing or auditing IT operational process
• 3+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5
• 3+ years of experience in a senior IT leadership position w/demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry.
• Recent roles & achievements that demonstrate clear expertise delivering & maintaining compliant Accounting, QA/QC, Manufacturing, Clinical, Quality, Facilities & IT applications, segregations of duty, interfaces & processes.
• Direct involvement as IT lead for at least one FDA inspection & for multiple annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties & SSAE-18 SOC Report reviews
• Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead.
• Demonstrated understanding of project management methodology, & experience adopting industry best practices. PMP, ITIL, or other formal certification is desired.

Skills:

• Strong knowledge of IT implications of cGMP, GCP & ICH guidelines, Part 11/Annex 11 for US, Canada & EU markets; SOX; & privacy regulations
• Solid GAMP5-based SDLC/validation skills
• Strong skills designing & auditing compliant IT operational processes including SDLC, Change, Access, Inventory, Data Protection/Backup, Service Continuity Management.
• Strong skills utilizing & administering GRC, QMS & LMS tools required.
• Skills with Veeva eTMF, ELN/LIMS, NetSuite, Coupa, ADP & SharePoint a plus.
• Collaborative Communication Skills:
• Ability to work with a diverse group of personalities & individuals
• Excellent document authoring, review & writing skills
• Strong verbal communication skills
• Ability to work independently, multitask, strong attention to detail & accuracy
• Proven ability to set schedules & meet deadlines

Base salary compensation range:

Bay Area Range: $171,000/yr - $225,000/yr

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.