Director of IT Operations, Regulatory Compliance
6 days ago
We are seeking a highly skilled and experienced IT professional to join our team as a Senior IT Director, GxP Systems. This is a critical role that will oversee the entire lifecycle of our IT GxP systems, ensuring seamless integrations between various GxP applications and systems, and guaranteeing data integrity and compliance across platforms.
Key Responsibilities- Manage the entire lifecycle of IT GxP systems, including orchestrating integrations, ensuring data integrity, and maintaining compliance.
- Oversee stakeholder commitments and cross-functional deliverables for Tech Ops, Clinical Operations, Biometrics, Drug Safety, and other GxP-regulated departments.
- Develop and implement administration standard operating procedures (SOPs), assist business teams with qualification and validation activities, and partner with Quality to oversee validation lifecycle activities.
- Oversee incident management and administrative activities, handle necessary escalations, and facilitate the resolution of incidents impacting core business systems.
- Develop and maintain GxP-related IT policies, procedures, and standards, ensuring all GxP applications and related IT processes comply with relevant regulations.
- Manage relationships with vendors and service providers for GxP applications.
- Ensure the development and upkeep of business continuity and disaster recovery plans for vital GxP systems.
- Bachelor's degree in computer science, engineering, or similar STEM concentration.
- 8+ years of direct IT experience in roles of increasing responsibility in project/program management, business analysis, or other delivery leadership roles within a life sciences IT organization.
- Strong understanding of IT infrastructure, system integration, data management, and Quality and Regulatory functions within regulated life sciences organizations.
- Demonstrated history of success executing the core functions of the role, including implementing standard GxP applications, SaaS systems, and implementing Incident, Problem Change, Version, Release, and Configuration management for GxP systems/applications.
- Experienced in gap analysis, remediation plans, corrective and preventive action (CAPA), and reviewing, modifying, and writing standard operating procedures (SOPs).
- Strong background in software/system development methodology (i.e., Agile, SDLC, ITIL) and project management/business analysis.
- Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements, standards, and guidelines.
- Adept at communicating complex solutions and value in business terms. Strong communication skills are critical, as well as the ability to adapt and learn in a fast-paced environment.
- Preferred but not required skills include experience with QMS, ServiceNow, and System Administration activities; proficiency in integration technologies and methodologies such as APIs, ETL, ESB, and middleware; experience with Veeva Vaults; and proficiency in process mapping and project management tools like Jira, Smartsheet, and Visio.
We offer a competitive compensation package, including a base salary range of $190,000 - $210,000 per year, an annual bonus based on company goals, and an equity (RSU) grant. Our market-leading benefits package includes 100% coverage for medical, dental, and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution, and more.
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