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Director It Gxp Jobs (NOW HIRING)

NJ · On-site

The Specialist, IT - GxP Technical Support is responsible for troubleshooting incidents, fulfilling service requests, supporting identity and access management, and documenting work in accordance ...

NJ · On-site

The Specialist, IT - GxP Technical Support is responsible for troubleshooting incidents, fulfilling service requests, supporting identity and access management, and documenting work in accordance ...

NJ · On-site

Position Summary The Manager, IT - GxP Systems & Compliance, is responsible for ensuring reliable, complaint, and audit-ready IT support for GxP manufacturing, QC laboratory, and related technical ...

NJ · On-site

Position Summary The Manager, IT - GxP Systems & Compliance, is responsible for ensuring reliable, complaint, and audit-ready IT support for GxP manufacturing, QC laboratory, and related technical ...

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Director It Gxp information

What is a Director IT GxP?

A Director of IT GxP is a senior leader responsible for overseeing all IT systems and processes that must comply with Good Practice (GxP) regulations, particularly in industries like pharmaceuticals or biotechnology. They ensure that technology solutions meet regulatory standards for quality, safety, and data integrity, supporting functions such as manufacturing, clinical trials, and quality control. Their role involves developing compliance strategies, managing audits and inspections, and collaborating with other departments to maintain regulatory alignment. This position is critical in ensuring that a company's IT infrastructure supports legal and industry requirements.

What are the key skills and qualifications needed to thrive as a Director IT GxP?

To thrive as a Director IT GxP, you need deep expertise in IT systems, regulatory compliance (particularly GxP), and significant experience in pharmaceutical or life sciences environments, often supported by a relevant degree. Familiarity with validation tools, quality management systems, and regulatory frameworks like FDA 21 CFR Part 11 is crucial. Exceptional leadership, risk management, and cross-functional communication are vital soft skills in this position. These competencies ensure that IT operations meet rigorous regulatory standards, support business goals, and maintain data integrity in highly regulated industries.

What are some common challenges faced by a Director IT GxP when ensuring regulatory compliance in a fast-paced pharmaceutical environment?

A Director IT GxP often encounters challenges such as keeping up with evolving regulatory requirements (like FDA, EMA, or MHRA guidelines) while managing complex IT systems that support critical business processes. Balancing the need for innovation with strict validation and documentation standards can be demanding, especially when implementing new technologies. Additionally, ensuring seamless collaboration across cross-functional teams—such as Quality Assurance, Regulatory Affairs, and IT—requires strong communication and project management skills to align objectives and maintain compliance throughout the system lifecycle.

What does a director of digital experience do?

A director of digital experience oversees the development and management of digital platforms, ensuring a seamless and engaging user experience across websites, apps, and other digital channels. They coordinate cross-functional teams, analyze user data, and implement strategies to improve digital engagement and performance.

What does a director of employee experience do?

A director of employee experience oversees initiatives to improve employee engagement, workplace culture, and overall satisfaction. They develop strategies, implement programs, and collaborate with HR and leadership to create a positive work environment that supports employee well-being and productivity.

What does a director of experience do?

A Director of Experience oversees the design and delivery of user or customer experiences to ensure satisfaction and engagement. They often coordinate cross-functional teams, analyze feedback, and implement strategies to improve overall experience, utilizing tools like user research and analytics. This role requires strong leadership, communication skills, and a focus on continuous improvement.

What are popular job titles related to Director It Gxp jobs?

For Director It Gxp jobs, the most frequently searched job titles are:

Infographic showing various Director It Gxp job openings in the United States as of September 2026, with employment types broken down into 2% As Needed, 85% Full Time, 12% Part Time, and 1% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution.

Specialist, IT - GxP Technical Support

Cranbury, NJ • On-site

Rocket Pharmaceuticals
Biotechnology Research and Development • 51 - 200 employees

$54K - $72K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 4 days ago


Job description

Overview
Create a future where DNA is no longer destiny. Join Rocket Pharma.
Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.
Position Summary
We are seeking a motivated, detail-oriented Specialist, IT - GxP Technical Support to provide first level helpdesk support for GxP-regulated and business-critical systems. This role supports end users while helping maintain a secure, compliant, and audit-ready IT environment.
The Specialist, IT - GxP Technical Support is responsible for troubleshooting incidents, fulfilling service requests, supporting identity and access management, and documenting work in accordance with approved procedures, change control requirements, validation expectations, and applicable regulatory standards. The position works closely with Quality Assurance (QA), Computer System Validation (CSV), Infrastructure, Security, Business System Owners, and vendors to ensure that regulated systems remain secure, compliant, and operational.
Responsibilities
  • Provide Tier 1+ support for GxP and non-GxP systems, endpoint devices, business applications, and user access issues.
  • Troubleshoot and resolve incidents affecting GxP-regulated applications, laboratory systems, quality systems, manufacturing systems, and supporting infrastructure.
  • Manage incidents and service requests through ServiceNow, ensuring accurate documentation, classification, prioritization, escalation, and closure in accordance with SLAs and GxP procedures.
  • Perform user provisioning, deprovisioning, and access modifications for GxP systems in accordance with approved access management procedures and segregation of duties expectations.
  • Support Identity and Access Management platforms including Okta, Active Directory, and Microsoft Entra ID, including SSO and MFA troubleshooting.
  • Assist with onboarding, offboarding, and role changes while ensuring appropriate approvals and audit trail documentation are maintained.
  • Support Windows, macOS, mobile devices, Microsoft 365, and endpoint management platforms within regulated and non-regulated environments.
  • Escalate GxP incidents to QA, CSV, Infrastructure, Security, System Owners, or vendors as required based on severity, risk, and potential regulatory impact.
  • Maintain accurate IT asset inventory records and lifecycle documentation for regulated systems and endpoints.
  • Create, update, and maintain SOPs, work instructions, knowledge base articles, and controlled support documentation.
  • Support internal and external audits by providing documentation, evidence, ticket history, and system support records as required.

Qualifications
  • Bachelor's Degree in Information Technology, Computer Science, Engineering, Life Sciences, or related discipline preferred; equivalent education and experience will be considered.
  • 1-3 years of experience supporting IT systems within a pharmaceutical, biotechnology, medical device, or other regulated environment.
  • Experience supporting GxP-regulated applications, systems, equipment, or processes.
  • Experience supporting Windows 10/11, macOS, Microsoft 365, and enterprise endpoint technologies.
  • Experience with user lifecycle management, access provisioning, SSO, MFA, and identity platforms such as Okta, Active Directory, and Microsoft Entra ID.
  • Understanding of change management, incident management, deviation management, and CAPA processes within regulated environments.
  • Experience supporting laboratory instruments, manufacturing systems, quality systems, or validated software applications is highly desirable.
  • Excellent written and verbal communication skills with the ability to interact effectively with technical and non-technical users.
  • Demonstrated ability to manage multiple priorities while maintaining a high degree of accuracy, documentation quality, and compliance.
  • Strong customer service orientation with a focus on responsiveness, professionalism, and clear communication.
  • Ownership and accountability for tickets, tasks, and issues through complete resolution.

Physical Requirements:
  • Ability to work outside of standard business hours on an occasional basis to support GxP activities, system implementations, upgrades, maintenance activities, audits, inspections, and critical issue resolution.
  • Ability to lift, carry, push, and/or pull equipment and materials weighing up to 25 pounds on an occasional basis.
  • Ability to wear required personal protective equipment (PPE) and comply with all safety, security, and GxP requirements while working in regulated environments
  • Ability to work in both office and regulated laboratory, manufacturing, and data center environments.

Compensation
The expected salary range for this position is $54,000 to $72,000.
At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market.
For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.
In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).
EEO Statement
A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.