What are the responsibilities and job description for the IT Director - Validated Systems | Remote Opportunity position at Get It - Professional Services?
Job Overview
We are seeking a highly skilled Director of IT Validated Systems to spearhead the management and validation of GxP-related systems, ensuring rigorous adherence to regulatory standards. The ideal candidate will possess strong leadership capabilities, exceptional communication skills, and a strategic mindset, enabling them to effectively prioritize and manage multiple projects within a dynamic environment.
Key Responsibilities
Our organization is committed to the professional development of our employees, providing avenues for continuous learning and advancement within the company.
Company Culture And Values
We embrace values of compassion, boldness, rigor, and inclusivity, fostering a collaborative work atmosphere where teamwork drives us toward achieving our shared goals.
Compensation And Benefits
We are proud to be an equal opportunity employer, dedicated to promoting diversity and inclusion. All applicants will be considered based on qualifications, skills, and experience, without regard to any discriminatory factors.
Sponsorship
Please note, we are currently unable to sponsor employment visas. Applicants must possess the right to work in the country of application.
Employment Type: Full-Time
We are seeking a highly skilled Director of IT Validated Systems to spearhead the management and validation of GxP-related systems, ensuring rigorous adherence to regulatory standards. The ideal candidate will possess strong leadership capabilities, exceptional communication skills, and a strategic mindset, enabling them to effectively prioritize and manage multiple projects within a dynamic environment.
Key Responsibilities
- Act as an IT Business Partner to the Quality, Clinical, and Regulatory teams, ensuring application support and compliance with internal policies.
- Manage vendor and service provider relationships, overseeing contracts and guiding the validation process.
- Take charge of prioritizing enterprise and operational projects while maintaining a high standard of communication.
- Collaborate with IT project managers to address resource and budget challenges, ensuring alignment with company objectives and IT budgetary constraints.
- Drive the development of IT PMO procedures, dashboards, and reports, providing data-driven insights to stakeholders.
- Lead a portfolio of compliance-focused IT projects to enhance Risk-Based System Life Cycle (SDLC), GxP Compliance, Inspection Readiness, and Audit Operational Preparedness.
- Ensure ongoing validation of GxP-related systems, managing their lifecycle and conducting comprehensive risk assessments.
- Partner with teams and service providers to create and maintain necessary SOPs, policies, and work instructions.
- Oversee Configuration and Change Management, Periodic Review, Audit Trail, Access Review, Periodic Restore, and Vendor Management processes for regulated systems.
- Represent the IT department at FDA Pre-Approval Inspections (PAI) and other regulatory audits.
- Extensive experience in validation engineering within the biotechnology or pharmaceutical industry.
- Strong understanding of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management.
- Proven ability to lead IT projects and manage teams successfully.
- Excellent problem-solving skills with an adaptable approach to changing priorities.
- Exceptional communication and interpersonal skills, fostering collaboration across cross-functional teams.
- Bachelor's degree in IT, Engineering, Computer Science, or a related field.
Our organization is committed to the professional development of our employees, providing avenues for continuous learning and advancement within the company.
Company Culture And Values
We embrace values of compassion, boldness, rigor, and inclusivity, fostering a collaborative work atmosphere where teamwork drives us toward achieving our shared goals.
Compensation And Benefits
- Base salary range: \(180,000 - \)220,000 per year (dependent on qualifications, skills, and location).
- Additional discretionary bonuses and equity options included as part of the total compensation package.
- A comprehensive benefits package is offered, including health and wellness programs, among other perks.
We are proud to be an equal opportunity employer, dedicated to promoting diversity and inclusion. All applicants will be considered based on qualifications, skills, and experience, without regard to any discriminatory factors.
Sponsorship
Please note, we are currently unable to sponsor employment visas. Applicants must possess the right to work in the country of application.
Employment Type: Full-Time
Salary : $180,000 - $220,000
