Associate Director, IT Compliance

Position: Associate Director, IT Compliance GxP Systems

Duration: Permanent / Direct hire

Salary range: $180k - $190k

Location: Onsite 3x/week in either location below

Waltham, MA

Conshohocken , PA

JOB DESCRIPTION

A growing mid-size pharmaceutical company is seeking an Associate Director, IT Compliance to join on a perm basis. This role will report to the Executive Director of IT R&D and Quality and will play an integral role in maturing the IT Governance in the organization, which is in the early stages. He/she’s responsibilities will span across multiple regulatory domains in the digital space including but not limited to GxP, GDPR, PII, and SOX. He/she will collaborate cross-functionally within the IT Organization as well as business functions such as Legal, HR, Finance, R&D, CMC, and Quality to ensure the seamless compliant operation of our IT systems and services. This position is a great way to establish the companies governance and bring their previous experience in GxP Quality and technology.

Key Responsibilities:

• Maintain the Technology Compliance Framework aligned with global regulations, organizational risks, and evolving guidance and industry standards.
• Lead implementation and maintenance of IT Policy & SOPs in support of general controls and GxP processes including validation lifecycle in collaboration with Quality.
• Collaborate with Infrastructure and CISO to enable security governance and risk management controls in mixed regulated use environment
• Implement innovative learning approaches to user community for IT compliance procedures and practices.
• Act as a liaison to for external partners to support their understanding of technology compliance requirements
• Audit Management focal point for internal/external audits of the IT organization (about 2 audits a year but need inspection readiness)
• Develop and monitor key performance indicators (KPIs) to evaluate framework effectiveness and identify improvement opportunities
• Maintain process for System Regulatory Assessments and associated IT Inventory
• Lead the selection, implementation, and maintenance of IT Tools for SDLC/VLC processes ( e.g. Requirement & Test Management solutions such as Veeva Validation, Kneat, Helix ALM, etc,)

REQUIRED SKILLS AND EXPERIENCE

• 8-10 years of life sciences experience collaborating with Infrastructure and CISO

• In-depth knowledge of GxP regulations related to Computer System Validation/Computer Systems Assurance

• Experience in developing validation approaches for infrastructure and cloud based Platforms.

• Non-Health ministry regulatory requirements background including GDPR, PII, and SOX

• Experience in using and/or implementing System Development Lifecycle and testing tools ( Example: Veeva Validatoin, KNEAT, HP ALM, QTest, JIRA for GxP

• Bachelor's degree in computer science, information technology