Senior Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities)

Bristol Myers Squibb • Madison, WI

1d

About The Position

The Senior Manager is responsible for providing quality oversight for Site Validation activities and Quality Control Laboratory method and equipment validation in accordance with BMS policies, standards, procedures, and Global cGMP. The role includes ensuring accurate and timely maintenance and review of validation and qualification documents for equipment and facility activities, and supporting site data integrity initiatives.

This role may be an individual-contributor or people-manager position. In the people-manager capacity, the Senior Manager leads a team with distinct roles and responsibilities and maintains alignment among business process owners, end users, and cross-functional groups. The position reports to the Associate Director, QA Operations - Quality Engineering.

Requirements

• Bachelor of Science degree required.
• Minimum of seven years of experience in the pharmaceutical or related industry.
• Knowledge of GMP, Quality, and in-depth risk management.
• Experience designing user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing, and other equipment, utility, or facility qualification documentation.
• Fluency in standard Microsoft Office software.
• Ability to recognize and group technical/scientific attributes and drive science-based decisions in technical areas.
• Ability to manage technical or scientific initiatives and activities conducted by interdisciplinary teams.
• Strong authorship skills and ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Ability to recognize patterns and trends in reported data and communicate strategic solutions to cross-functional stakeholders.
• Ability to complete tasks with minimal direction, obtain resources and information through internal contacts, and consult a supervisor on decisions outside established processes.
• Ability to manage experienced professional employees and make daily decisions that impact the team.
• Ability to guide employees in interpreting technical/scientific issues across most of the job function.
• Ability to routinely recognize and resolve Quality issues, propose solutions, and develop procedures.
• Ability to independently interpret complex results and situations and articulate recommendations for solutions.
• Ability to recognize risks and develop contingency plans, and to negotiate solutions cross-functionally.
• Action-oriented and customer-focused, with skills in decision-making, relationship building, problem solving, conflict management, planning and organizing, resource allocation, coaching, and analytical thinking.
• Understanding of fundamental scientific problems, CAPAs, and root cause analysis (RCA).
• Ability to write and review reports with clarity and brevity.

Nice To Haves

• Experience with a Computer Maintenance Management System such as Maximo.
• Experience with quality systems software such as BMSDocs Electronic Document Management System or Infinity/Valgenesis.

Responsibilities

• Support all activities for the QA Engineering group.
• Support qualification and validation activities related to QC and manufacturing equipment, utilities, and facility design.
• Ensure the appropriateness of calibration and maintenance programs, validation plans, qualification protocols, associated reports, and procedures.
• Ensure compliance with the site validation master plan and support facility start-up operations and product transfers with Qualification and Validation teams.
• Ensure site compliance with global and regulatory data governance and data integrity requirements; establish and maintain procedures that uphold data integrity and compliance.
• Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
• Ensure the site stability program meets global and regulatory requirements.
• Ensure method qualifications, method transfers, and analyst training meet company and regulatory requirements.
• Manage the QA Engineering team and ensure job objectives are met in a timely manner.
• Provide quality oversight for site validation activities and QC laboratory method and equipment validation.
• Maintain alignment among business process owners, end users, and cross-functional groups when serving as a people manager.
• Recognize and resolve quality issues, propose solutions, develop procedures, and inform management of proposed solutions.
• Interpret complex results and situations, articulate recommendations, recognize risks, develop contingency plans, and negotiate cross-functional solutions.
• Drive continuous improvement and increase efficiency and productivity within the group or project.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays each year.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior