Sr Manager QA Technical Operations

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. 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:  .PRINCIPAL OBJECTIVE OF THE POSITION:

Provide Leadership to a team of Quality managers with oversight and support for Quality Control projects as well as daily activities. Manages and oversees operations for Cell Banking, Local Site Change Controls, QA for Technology Transfer, QA for Automation and QA for Validation, and QA for MS&T and Site Engineering Maintenance programs. May assist in preparing for and hosting of regulatory and customer audits.

Major Duties and Responsibilities Provides direct supervision of personnel approving change controls, protocols/reports and investigations in support validation and automation teams.

Provides direct supervision of personnel reviewing manufacturing maintenance, calibration and scheduling programs for preventive maintenance and calibrations.

Provides supervision of personnel managing the quality approval of all technical transfer documentation, including PPQ, PD, FFR, M , Formula Set and system Master Data Interfaces in clinical and commercial tech transfer meetings, including with stakeholders from OE, MT, MST, PD, CMC, QPL and relevant organizations supporting transfer to manufacturing areas.

Accountable to tracking and managing risks and decisions coming out of technical transfer sub-teams and coordinating resolution with Quality Tech Transfer Lead and QA AD.Makes decisions and communicates on minor tech transfer decisions and risks. Keeps track of tech transfer milestones for resource allocation

May represent quality in Tech Transfer Governance Meetings Represents quality in project meetings

Supports approval of tech transfer driven risk assessments and updates, coordinating closely with field quality operations

Collaborates with other functional area managers in planning and scheduling of resources.

Performs review and approval of site and department SOPsDevelop and manage the training curriculum of direct reports as it relates to the execution of department related processes.

Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products

Directly participates in internal audits or reviews as well as global health authority inspections

Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives with a constant display of the BMS behaviors.

Provides direct supervision of personnel approving change controls, protocols/reports and investigations

Supports and approves complex operational investigations

Knowledge and Skill Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is requiredA minimum of 8 years’ experience in biopharmaceutical operations with 2 years of prior management experience desirable

Experience in building and growing an…