Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead

At Bristol-Myers Squibb, we are committed to transforming patients' lives through innovative medicines and therapeutic solutions. We are seeking a talented and experienced Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead to join our dynamic team. As a leader in our IT department, you will play a critical role in ensuring compliance and efficiency in our GxP computer systems and processes. If you are passionate about driving excellence in IT and have a strong background in GxP computer systems validation, we encourage you to apply for this exciting opportunity.

1. Develop and implement strategies for GxP computer systems validation that align with company goals and regulatory requirements.
2. Lead and manage a team responsible for GxP computer systems validation and IT processes.
3. Ensure all GxP computer systems are compliant with relevant regulations and guidelines, such as FDA 21 CFR Part 11 and EU Annex 11.
4. Conduct risk assessments and develop mitigation plans for potential compliance issues.
5. Collaborate with cross-functional teams to identify and address any issues with GxP computer systems validation.
6. Stay current with industry trends and changes in regulatory requirements related to GxP computer systems validation.
7. Serve as the subject matter expert for GxP computer systems validation and advise other departments on best practices.
8. Develop and maintain standard operating procedures and policies for GxP computer systems validation.
9. Oversee all validation activities, including documentation, testing, and reporting.
10. Lead audits and inspections related to GxP computer systems validation and IT processes.
11. Identify opportunities for process improvements and implement changes to streamline and optimize validation processes.
12. Train and mentor team members on GxP computer systems validation and IT processes.
13. Manage relationships with external vendors and partners involved in GxP computer systems validation.
14. Communicate regularly with senior management to provide updates on the status of GxP computer systems validation and IT processes.
15. Ensure all GxP computer systems validation projects are completed on time, within budget, and according to company standards.

According to JobzMall, the average salary range for a Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead in Indianapolis, IN, USA is $130,000-$160,000 per year. This may vary depending on the specific company, industry, and level of experience of the individual.

Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.