Senior Specialist, Records Management Lead

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Key Responsibilities:

• Execution and maintenance of documentation lifecycle for all site documents from initiation, processing, routing, distributing, and archiving of site documentation to ensure site compliance with current regulatory, cGMP and BMS corporate policies and directives.

• Able to organize and prioritize workload to ensure timely and efficient support to all functional departments.

• Serves as a subject matter expert for the electronic document management system, record archival and GMP compliance topics.

• Support and participate in regulatory agency inspections, e.g., FDA, EMEA, etc., and corporate compliance site audits.

• Establish and communicate performance objectives for Quality Assurance-Records Management staff that are consistent with the business’ unit goals, Quality and Technical Operations objectives.

• Exhibit leadership, guidance, and problem-solving skills within the department and as member of cross functional teams.

• Ability to review processes and identify efficiencies to streamline and ensure process is executable and compliant.

• Responsible for site administrative operations for the electronic document management system.

Qualifications & Experience:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent is preferred.

• A minimum of 4 or more years’ experience in biopharmaceutical quality including a minimum of 2 years of direct document management experience in a regulated environment focused on product quality is required.

• Strong teamwork and communication skills and the ability to follow written and verbal instructions are required.

• Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics in FDA regulated environment.

• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.

• Extensive knowledge of US and EU cGMP regulations and guidance.

• Experience with FDA/EU Preapproval Inspection preparation and management is essential.

• Demonstrated organizational leadership, interpersonal, communication, and motivation skills.

• Expertise in an electronic document management system.

• Knowledge of Infinity and SAP or similar software programs desirable.

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. 

• Acts as an advisor to less experience staff to resolve problems. 

• Establishes and recommends changes to policies which affect the organization. 

• May work on assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. 

• Failure to obtain results or erroneous decisions or recommendations would typically result in minor program delays.

• Receives assignments in the form of objectives and establishes goals to meet objectives.

• Work is reviewed and measured based on meeting established objectives and schedules. 

• Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.

#BMSBL

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-chan