What are the responsibilities and job description for the Remote Director of IT Systems - Validated | WFH position at Get It - Professional Services?
Job Overview
We are seeking an accomplished Director of IT Validated Systems to spearhead the management and validation of Good Practice (GxP) related systems, ensuring strict adherence to regulatory requirements. The successful candidate will be an influential leader with exceptional communication skills and a strategic mindset, adept at prioritizing and managing multiple projects effectively. This hands-on role is vital for maintaining the highest quality and compliance standards throughout the organization.
Key Responsibilities
This position presents a unique opportunity to assume significant responsibilities, engage in high-impact projects, and further develop professionally within a dynamic and supportive environment. Mentorship and collaboration with diverse teams are integral aspects of this role.
Company Culture And Values
Our organization champions values of compassion, boldness, rigor, and inclusivity, nurturing a collaborative atmosphere where cross-functional teams can flourish. We prioritize diversity and inclusion, ensuring all employees feel valued and supported.
Compensation And Benefits
We are an equal opportunity employer, committed to fostering diversity and inclusion. We ensure that all applicants are evaluated based on qualifications, skills, and experience, without discrimination on any grounds.
Sponsorship
Please be advised that we are currently unable to sponsor employment visas. Candidates must have the right to work in the country of application.
Employment Type: Full-Time
We are seeking an accomplished Director of IT Validated Systems to spearhead the management and validation of Good Practice (GxP) related systems, ensuring strict adherence to regulatory requirements. The successful candidate will be an influential leader with exceptional communication skills and a strategic mindset, adept at prioritizing and managing multiple projects effectively. This hands-on role is vital for maintaining the highest quality and compliance standards throughout the organization.
Key Responsibilities
- Act as an IT Business Partner to the Quality, Clinical, and Regulatory teams, offering support for applications while ensuring compliance with internal policies and procedures.
- Lead vendor and service provider relationships, overseeing contracts and guiding the validation process.
- Take ownership of prioritizing both enterprise and operational projects, maintaining high levels of communication.
- Collaborate with IT project managers to tackle resource and budget challenges, aligning projects with organizational goals and budget constraints.
- Contribute to the establishment of IT project management office (PMO) procedures, dashboards, and reports.
- Provide data-driven insights to stakeholders, ensuring projects adhere to best practices.
- Manage a portfolio of compliance-centric IT projects aimed at enhancing Risk-Based System Life Cycle (SDLC), GxP Compliance, Inspection Readiness, and Audit Operational Preparedness.
- Oversee the validation lifecycle of GxP-related systems, conducting thorough risk assessments.
- Partner with teams and service providers to develop essential Standard Operating Procedures (SOPs), policies, and work instructions.
- Supervise Configuration and Change Management, Periodic Review, Audit Trail, Access Review, Periodic Restore, and Vendor Management processes for regulated systems.
- Represent the IT department during FDA Pre-Approval Inspections (PAI) and other regulatory audits.
- Strong leadership and project management capabilities.
- Excellent communication and interpersonal skills, fostering collaboration with cross-functional teams.
- Comprehensive knowledge of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management.
- Proven problem-solving abilities and adaptability to changing priorities.
- Bachelor's degree in Information Technology, Engineering, Computer Science, or a related discipline.
- Extensive experience in validation engineering within the biotechnology or pharmaceutical sector.
- Demonstrated success in leading IT projects and managing teams effectively.
This position presents a unique opportunity to assume significant responsibilities, engage in high-impact projects, and further develop professionally within a dynamic and supportive environment. Mentorship and collaboration with diverse teams are integral aspects of this role.
Company Culture And Values
Our organization champions values of compassion, boldness, rigor, and inclusivity, nurturing a collaborative atmosphere where cross-functional teams can flourish. We prioritize diversity and inclusion, ensuring all employees feel valued and supported.
Compensation And Benefits
- Base salary range: \(180,000 - \)220,000 annually (dependent on qualifications, skills, and location).
- Additional discretionary bonuses and equity options available as part of the overall compensation package.
- A comprehensive benefits package is provided, including health and wellness programs and more.
We are an equal opportunity employer, committed to fostering diversity and inclusion. We ensure that all applicants are evaluated based on qualifications, skills, and experience, without discrimination on any grounds.
Sponsorship
Please be advised that we are currently unable to sponsor employment visas. Candidates must have the right to work in the country of application.
Employment Type: Full-Time
Salary : $180,000 - $220,000
