Ad/ Director Of Gxp Systems

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Job description

Job Purpose

As part of the Ocugen team, the Director of GxP Systems will design, implement, and maintain Ocugen Veeva suits such as eTMF, CTMS, CDMS, RTMS, eQMS, QualityDoc, Training, Safety, and RIMS, as well as any other GxP applications, to meet regulatory requirements and business needs.

The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. This position is located in Malvern, PA, USA.

Duties and responsibilities

Accountable for implementation/delivery of Veeva Suits applications to meet Ocugen business needs with a focus on regulated functions:

• Develop and own Ocugen GxP Compliance program, with AWS Cloud & SaaS Application Validation/Qualification expertise.
• Collaborate with IT and business leaders to select, design, install, and validate GxP Systems, adhering to industry standards like GAMP 5 and established Quality Standards.
• Manage application lifecycles for enterprise GxP 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 GxP standards and procedures, encompassing architecture, security, backups, disaster recovery, and data integrity standards.
• Partner with Clinical, Research and Development, Quality, and Regulatory team members to oversee systems validation, periodic reviews, and vendor coordination to ensure regulatory compliance and alignment with industry standards.
• Adhere to GxP functional and application administration, ensuring GxP systems, data, and processes meet required service levels and compliance protocols.
• Manage the deployment, monitoring, maintenance, development, upgrade, and support of GxP systems.
• Analyze, benchmark, report on, and recommend improvements for the GxP infrastructure and systems.
• Conduct third-party vendor risk assessments and audits, if needed.
• Establish a comprehensive enterprise information security program to ensure the integrity, confidentiality, and availability of relevant patient data.
• Manage relationships with external technology vendors, service providers, and strategic partners to ensure the timely delivery of high-quality services and solutions
• Negotiate contracts and service level agreements (SLAs) to achieve favorable terms and conditions while meeting business needs
• Provide technical leadership to project managers, business analysts, and programmers on application/data analytics project teams.
• Work with business owners to formulate and conduct training sessions and teaching materials to propagate enterprise applications knowledge throughout the organization.
• Recommend, schedule, and perform software improvements, patches, upgrades, and/or purchases.
• Deep understanding of the necessary activities required to drive IT compliance to support regulatory filing, regulatory inspection, and commercial launch.
• Document/diagram functional process flows to ensure optimization and synchronization of systems, including identifying/advising on best applications for specific business processes, including cloud-based systems.

Qualifications

Qualifications

• Bachelor's or Master's Degree in computer science or technology with multiple years of Direct Veeva Vault/System Administration Experience.
• Ten plus (10+) years of experience working on validated applications in a pharmaceutical or regulated environment.
• Experience and knowledge of quality, clinical, and regulatory business processes.
• Direct hands-on experience implementing GxP computerized systems and maintaining validated state.
• Demonstrated strategic thinking abilities and an enterprise-wide perspective
• Expertise in IT infrastructure and architecture, cybersecurity, and data management practices
• Strong process improvement skills and orientation.
• Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment.
• Proven strong communication skills in interacting with users and technical communities.
• Ability to communicate ideas in both technical and user-friendly language.
• Collaborative working approach.

Computer Skills:

• Certified Veeva System Administrator for various Suites - Required.
• Knowledge of 21 CFR Part 11, Annex 11, data integrity, and CSV process and clear vision for establishing a validation service to GxP stakeholders.
• Veeva Vault Owner/System Administration Experience required for eTMF, CTMS, CDMS, RTMS, eQMS, QualityDoc and Training, Safety, and RIMS
• Experience with Other Regulated Applications would be an asset
• Database and computer networking knowledge
• Experience working on SaaS (Software as a Service) systems

Working conditions

This position operates primarily in an office setting and may include 10% of travel.

Physical requirements

This is a largely sedentary role. This position is located in Malvern, PA, USA.

Direct reports

This position may have direct reports.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,
current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.

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