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

Bristol Myers Squibb • Madison, NJ

2d • $122,150 - $148,011

About The Position

The Senior Manager provides quality oversight for site validation activities and Quality Control laboratory method and equipment validation in accordance with Bristol Myers Squibb policies, standards, procedures, and global cGMP requirements. The role ensures accurate and timely maintenance and review of validation and qualification documents for equipment and facility activities and supports site data integrity initiatives.

The position may be an individual contributor or a people manager. In the people-manager capacity, it leads the QA Engineering team and maintains alignment among business process owners, end users, and cross-functional groups. The role supports qualification and validation activities for QC and manufacturing equipment, utilities, and facilities; laboratory compliance; site stability programs; method qualifications and transfers; and analyst training. It reports to the Associate Director, QA Operations - Quality Engineering.

Requirements

• Bachelor of Science degree.
• At least seven years of experience in the pharmaceutical or a related industry.
• GMP, Quality, and in-depth risk management knowledge.
• 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 or scientific attributes and make science-based decisions.
• Strong authorship and critical review skills for investigations and reports; ability to interpret results and form technical conclusions consistent with Quality risk management principles.
• Ability to recognize patterns and trends in data and communicate strategic solutions to cross-functional stakeholders.
• Ability to work with minimal direction, obtain resources and information through internal contacts, and consult a supervisor for decisions outside established processes.
• Ability to guide employees in interpreting technical and scientific issues and manage interdisciplinary initiatives.
• Ability to recognize and resolve quality issues, propose solutions, develop procedures, and seek management guidance on complex issues.
• Ability to independently interpret complex results and situations and articulate recommended solutions.
• Ability to recognize risks and develop contingency plans, negotiate cross-functional solutions, and drive continuous improvement.
• Skills in decision-making, relationship building, problem solving, conflict management, planning and organizing, resource allocation, coaching, and analytical thinking.
• Understanding of fundamental scientific problems, CAPA, and root cause analysis (RCA).
• Ability to write and review reports with clarity and brevity.

Responsibilities

• Support all activities for the QA Engineering group.
• Support qualification and validation activities relating to QC and manufacturing equipment, utilities, and facility design.
• Ensure calibration and maintenance programs, validation plans, qualification protocols, associated reports, and procedures are appropriate.
• Ensure compliance with the site validation master plan and assist with facility start-up operations and product transfers in support of Qualification and Validation teams.
• Ensure the site complies with global and regulatory data governance and data integrity requirements.
• Establish and maintain procedures to preserve data integrity and ensure procedures and processes are compliant.
• 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 on time.
• Lead or support interdisciplinary technical and scientific initiatives, resolve quality issues, develop procedures, and drive continuous improvement and efficiency.

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 company holidays: 11 annually.
• For specified employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval, and three optional holidays.
• 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.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary cash incentives and stock opportunities.

What This Job Offers

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