R & D IT Compliance Lead (Contract role)

The R & D IT Compliance Lead at Zifo is responsible for ensuring that IT operations comply with GxP regulations. This includes managing the compliance program, developing effective partnerships with various stakeholders, and overseeing critical compliance activities such as System Validation, IT Change Management, and Data Protection. You'll also lead compliance-related audits and inspections, making sure that documented evidence supports compliance objectives.

Candidates for the R & D IT Compliance Lead role at Zifo should possess a Bachelor’s or Master’s degree in biology, biomedical engineering, chemistry, or a related field. Moreover, over 10 years of experience in the Lifesciences industry, with a solid background in System Validation, Quality Assurance, and GxP regulations, is required. Extensive expertise in IT Change Management and the Software Development Life Cycle is also necessary.

Yes, the R & D IT Compliance Lead position at Zifo is indeed open to independent contractors. This flexible contract role requires just three days a week on-site at our client location in Emeryville, CA, creating a perfect balance for professionals seeking a skilled role in IT compliance without a full-time commitment.

For the R & D IT Compliance Lead role at Zifo, the expected work arrangement is a contract position requiring three days per week on-site at the client's location in Emeryville, CA. This setup allows you to maintain a flexible work-life balance while contributing significantly to the compliance efforts of our Life Science clients.

The R & D IT Compliance Lead at Zifo needs to have considerable experience acting as the primary IT contact for GxP compliance audits and inspections. You should be well-versed in managing these audits and ensuring compliance objectives are met through effective partnerships and well-documented evidence.

When addressing GxP compliance, I would focus on establishing a robust compliance program that includes regular audits, risk assessments, and tailored training for staff. This ensures everyone understands their roles and responsibilities and adheres to the established guidelines.

In my previous roles, I have been deeply involved in system validation processes where I ensured that all IT systems met the required quality standards before being deployed. This involved developing validation protocols, conducting system testing, and documenting findings to maintain compliance.

I prioritize a structured Change Management process that includes thorough documentation, risk assessments, and approvals from relevant stakeholders. This ensures that any alterations to IT systems are compliant with regulations and do not disrupt operational integrity.

I spearheaded a compliance training initiative by tailoring the content to the specific roles within the organization. By incorporating interactive elements, quizzes, and real-world scenarios, I engaged participants and ensured they could apply the knowledge practically.

I like to use a combination of qualitative and quantitative metrics, such as audit findings, compliance training completion rates, and incidents related to non-compliance. Regularly reviewing these metrics allows me to identify areas for improvement in the compliance program.

One of the greatest challenges in maintaining IT compliance in the Life Sciences industry is navigating the rapidly changing regulations and ensuring that all systems and processes are aligned with these changes while still supporting the innovation needs of the business.

I ensure that the teams are well-prepared by conducting mock audits ahead of scheduled inspections, reviewing documentation, and ensuring that everyone understands their roles. Effective communication and a thorough understanding of compliance requirements yield positive results during any audit.

Documentation is critical in IT compliance as it provides evidence that regulatory requirements have been met, supporting both internal and external audits. Properly maintained documentation promotes accountability, facilitates knowledge transfer, and demonstrates a commitment to compliance.

I actively participate in industry forums, subscribe to relevant publications, and engage in continuous education through courses and certifications. Staying connected with other professionals in the field also helps me remain informed about evolving compliance landscapes.

I prioritize open communication and regular collaboration with stakeholders to understand their needs and concerns. Building trust through transparency and providing them with the necessary support ensures a strong partnership focused on achieving compliance goals.