Sr Manager QA Technical Operations

About the role

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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment, offering a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals, both at work and in their personal lives.

Principal Objective

Provide leadership to a team of Quality managers with oversight and support for Quality Control projects as well as daily activities. Manage and oversee 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 regulatory and customer audits.

Responsibilities

• Provides direct supervision of personnel approving change controls, protocols/reports, and investigations in support of 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, MBR, 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 for tracking and managing risks and decisions from 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.
• Tracks 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 resources.
• Performs review and approval of site and department SOPs.
• Develops and manages the training curriculum of direct reports as it relates to department-related processes.
• Contributes to and supports the site team in preparing for, hosting, and responding 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 department goals and objectives with a constant display of BMS behaviors.
• Supports and approves complex operational investigations.

Requirements

• Bachelor’s degree in science, engineering, biochemistry, or a related discipline.
• A minimum of 8 years’ experience in biopharmaceutical operations, with 2 years of prior management experience desirable.
• Experience in building and growing an organization into a high-performance team.
• Strong background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing.
• Knowledge of biotech bulk and finished product manufacturing and analytical testing is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge and proven experience with FDA, EMA, or other regulatory authorities.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Knowledge of applicable business systems including SAP, LIMS, Maximo, Syncade, DeltaV, and Veeva Vault.

Qualifications

• Bachelor’s degree in science, engineering, or other related discipline.
• A minimum of 5 years' experience in biopharmaceutical quality or its equivalent, with an additional 2-3 years of increasing responsibility.
• Experience and a demonstrated track record of success leading teams with a wide range of responsibilities.
• Ability to develop and lead a team of professionals who can interact effectively across all levels and functions of the organization.
• Excellent written and oral communication skills.
• Capability to build alignment with peer-level business partners.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Demonstrated capability to make and act on decisions while balancing speed, quality, and risk.

Pay

Devens - MA - US: $130,020 - $157,559. The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • Paid Time Off:
    • US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
    • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day.

Schedule

BMS has an occupancy structure that determines where an employee is required to conduct their work. This role is site-by-design, which may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.