Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead
Are you a seasoned IT professional with a passion for ensuring compliance and efficiency in GxP computer systems? Do you have experience leading cross-functional teams and driving IT process improvements? If so, Bristol-Myers Squibb has an exciting opportunity for you to join our team as a Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead. In this role, you will play a critical role in maintaining the integrity of our GxP computer systems and optimizing our IT processes to support our mission of delivering life-changing medicines to patients. To excel in this role, you must have a strong understanding of GxP regulations and experience implementing and maintaining validated systems in a pharmaceutical or biotech environment. Additionally, you must possess exceptional leadership, communication, and project management skills. Join us and make a meaningful impact on the lives of patients around the world.
- Lead the validation and compliance efforts for GxP computer systems within the organization.
- Collaborate with cross-functional teams, including Quality, Regulatory, and IT, to ensure GxP systems are compliant with regulations and company policies.
- Develop and implement strategies to continuously improve IT processes and systems.
- Monitor and maintain the integrity of GxP computer systems through regular assessments and audits.
- Provide guidance and training to IT and business teams on GxP regulations and compliance requirements.
- Act as a subject matter expert for GxP computer systems and keep up-to-date with industry standards and best practices.
- Lead projects to implement new GxP systems and upgrades, ensuring proper validation and compliance.
- Develop and maintain relationships with external vendors and partners to ensure compliance and efficiency of GxP systems.
- Oversee the creation and maintenance of all validation and compliance documentation for GxP systems.
- Manage and develop a team of IT professionals to support GxP computer systems and processes.
- Communicate regularly with senior leadership to provide updates on GxP system compliance and process improvements.
- Troubleshoot and resolve any issues related to GxP computer systems in a timely manner.
- Ensure all GxP systems are appropriately maintained and validated throughout their lifecycle.
- Drive a culture of compliance and efficiency within the IT department and across the organization.
- Stay current with industry trends and regulatory changes to continuously improve GxP systems and processes.
Extensive Experience In Gxp Computer Systems Validation: The Ideal Candidate Should Have At Least 10 Years Of Experience In Gxp Computer Systems Validation, With A Thorough Understanding Of Fda And Global Regulatory Requirements.
Strong Leadership Skills: As A Senior Manager, This Individual Will Be Responsible For Leading A Team Of It Professionals. They Should Possess Excellent Leadership Skills, Including The Ability To Mentor And Coach Team Members, Manage Conflicts, And Make Tough Decisions.
In-Depth Knowledge Of It Processes: The Candidate Should Have A Deep Understanding Of It Processes, Including Software Development Life Cycle, Change Management, And Risk Management. They Should Also Be Familiar With Industry Best Practices And Standards Such As Gamp 5 And 21 Cfr Part 11.
Experience In Pharmaceutical Industry: Bristol-Myers Squibb Is A Global Biopharmaceutical Company, And The Ideal Candidate Should Have Experience Working In The Pharmaceutical Industry. This Will Ensure They Have A Good Understanding Of The Unique Challenges And Regulations In This Field.
Excellent Communication And Stakeholder Management Skills: As A Lead On Critical It Projects, The Senior Manager Should Possess Strong Communication And Stakeholder Management Skills. They Should Be Able To Effectively Communicate With Cross-Functional Teams, Senior Management, And External Stakeholders To Ensure Successful Project Delivery.
Risk Management
Quality Assurance
Change Management
Process Improvement
Project Management
Vendor Management
Validation
Team Management
Leadership
Compliance
Regulatory Requirements
It Strategy
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead in Indianapolis, IN, USA is between $120,000 and $150,000 per year. This may vary depending on the specific company, experience level, and other factors.
Apply with Video Cover Letter Add a warm greeting to your application and stand out!
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.
Get interviewed today!
JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.
Get Started