Director, IT Quality Compliance (GxP)
Location: California (East Bay)
On-site commitment: 4 days a week
HireMinds is partnered with a biotech company focused on peptide drug development, with a vision of bringing commercial products to market. We are seeking your expertise in IT compliance. As the Director of IT Quality you’ll lead the organization in implementing and maintaining IT GxP policies, procedures, and best practices. This pivotal role focuses on ensuring compliance with regulatory requirements for GxP Computer Systems, while also optimizing IT operations. You’ll be part of a team seeking commercial approval of drugs for patients in need and contribute to critical compliance implementation in the role. If you are excited about this role apply today!
Your Responsibilities:
- Develop and own the IT GxP Compliance program, with expertise in AWS Cloud & SaaS Application Validation/Qualification.
- Collaborate with IT and business leaders to select, design, install, and validate GxP Systems, adhering to industry standards like GAMP 5 and established Quality Directives.
- Manage application lifecycles for enterprise GxP IT systems, including change control, testing, validation, and communication.
- Lead or assist in deviation/incident investigations related to corporate GxP information systems, overseeing the implementation of Corrective Actions / Preventive Actions (CAPA).
- Create execution plans for IT GxP policies and procedures, encompassing architecture, security, backups, disaster recovery, and data integrity standards.
- Partner with Tech Ops, Quality, and Regulatory team members to oversee systems validation, periodic reviews, and vendor coordination to ensure regulatory compliance and alignment with industry standards.
- Maintain adherence to GxP functional and applications administration, ensuring IT systems, data, and processes meet required service levels and compliance protocols.
- Manage the deployment, monitoring, maintenance, development, upgrade, and support of GxP IT systems.
- Analyze, benchmark, report on, and recommend improvements for the IT GxP infrastructure and systems.
- Conduct third-party vendor risk assessments and audits.
You’ll Bring:
- Bachelor’s degree in computer science or related IT fields, with 10+ years of industry experiences in IT compliance under GxP regulated environments.
- Proficiency in GxP compliance and validation specifically with: GAMP5, 21 CFR Part 11, and ICH guidelines.
- Hands-on experience in qualifying/validating production systems to meet regulatory requirements.
- Knowledge of Software as a Service (SaaS) systems, automated process equipment, and clinical data management software in biotechnology or pharmaceutical settings.
- Experience in gap analysis, remediation plans, CAPA processes, and SOP review and development.
- Expertise in System Administration, Change Management, Data Integrity, ALCOA+, and 21 CFR Part 11.
- Strong technical understanding of current network hardware, protocols, and standards.
- Familiarity with project management principles and experience working in collaborative, team-oriented environments.
- Previous experience representing IT during audits and Regulatory inspections.
- Ability to work collaboratively and help teams push towards successful drug launch in an evolving biotech environment.
Compensation:
Salary: $190,000 to $225,000
Bonus: 15-20%
Stock considerations, health, dental, and 401k plan