Sr. Manager/ Associate Director Regulated Systems (GxP, BioTech) – Westlake Village, Ca Contract or Contract to Hire

Job Summary 

We are seeking another Senior Manager/Associate Director Regulated Systems contractor to partner, manage and help lead the IT Regulated Systems environment as the company grows rapidly. Primary responsibilities will be to support and provide administration over Regulated GxP Systems as well as manage GxP System project development, implementation, and change control. This is a client-facing, hands-on position.

Roles & Responsibilities 

GxP System Implementation 

• Maintains the Regulated Systems environment.
• Assess and resolve all high priority project risks as they are encountered
• Evaluate trade-offs between project size and complexity, cost, urgency, risk, and stakeholder value
• Provides technical guidance and support on all CSV deliverables.
• Responsible for the review and approval of all applicable CSV deliverables for each project, as defined in the Master Validation Plan for the project and as guided in Deliverables Matrix.
• Manages and oversees team members (FTE and Contractors) in system administration, maintenance, and change control activities.
• Develops, reviews, and approves procedures defining System Administration.
• Responsible for the Administration of the system’s security and ensuring that corporate security policies are followed.
• Partners with Corporate IT on all matters related to Single-Sign-On and security policy adherence.
• Responsible for providing controlled retention of all validation documentation for regulated systems during the applicable retention period.
• Ensures business systems used for applicable regulatory requirements are maintained in a validated state.

GxP System Administration 

• Provide Oversight and administrative control over all GxP IT Systems.
• Periodic review of GxP Systems.
• Responsible for developing, reviewing, and approving the processes that govern the administration and maintenance of the system.
• Partner with Business Owner and/or IT System Owner to review Access request forms, addition of users, and completion of all forms
• Responsible for developing, reviewing, and approving the processes that will govern the administration and maintenance of the system.
• Responsible for the Administration of the system’s security and ensuring that corporate security policies are followed.
• Maintains the IT Regulated Systems List and Change management log

Change Management/Incident Management 

• Manage Incidents related to GxP System Issues and escalation to Change Management.
• Authoring, Reviewing, and Approving IT Change Control deliverables.
• Responsible for technical impact and risk of the change.
• Ensuring the availability, support, and maintenance of a system and the security of the data residing on that system remains throughout the change process.
• Confirms business systems used for applicable regulatory requirements are maintained in a validated state.
• Responsible for tracking all Change Control Forms (CCF).
• Responsible for providing controlled retention of all documentation for regulated systems during the applicable retention period.

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