Sr Manager QA Technical Operations

Bristol Myers Squibb • Devens, MA

1d • Onsite

About The Position

Bristol Myers Squibb is seeking a Sr Manager QA Technical Operations to provide leadership to a team of Quality managers. This role involves oversight and support for Quality Control projects, daily activities, and operations for Cell Banking, Local Site Change Controls, QA for Technology Transfer, QA for Automation, QA for Validation, and QA for MS&T and Site Engineering Maintenance programs. The position may also assist in preparing for and hosting regulatory and customer audits. Bristol Myers Squibb offers a work environment that values balance and flexibility, with a wide variety of competitive benefits, services, and programs designed to support employees' goals both professionally and personally.

Requirements

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required.
• 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 US and EU cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Knowledge of applicable business systems including SAP, LIMS, Maximo, Syncade, DeltaV and Veeva Vault.
• 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 across all levels and functions of the organization effectively.
• Excellent written & oral communications 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 & objectives.
• Demonstrated capability with ability to make and act on decisions while balancing speed, quality and risk.

Nice To Haves

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

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 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 SOPs.
• Develop 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.

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 include: 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 for employees 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 Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

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