Computer System Validation Quality Manager, Cell Therapy

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Summary

Bristol Myers Squibb is seeking a Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA. This individual will be responsible for providing Quality oversight to Computer Systems Validation (CSV) activities and IT change management for the startup and continuing operations of the Devens Cell Therapy Facility.

This role is stationed in Devens, MA and reports to the Sr. Manager, Quality Engineering – Computer Systems for the Devens Cell Therapy Facility.

Job Responsibilities

• Provides document review and approval for computer system validation documentation from both technical and compliance perspectives.

• Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.

• Reviews and approves protocol discrepancies associated with the qualification and startup of the Devens Cell Therapy Facility and participates in resulting investigations and correction / corrective action planning.

• Supports the administration and maintenance of the site technical review board and IT change management process, assuring consistency with establishing standards for local and global change control systems

• Identifies unresolved issues/decisions related to validation documents and coordinates resolution with other departments.

• Demonstrates appropriate examples for compliance behaviors and attitudes, thereby shaping the culture.

• Meets and exceeds all safety expectations and adheres to all BMS behaviors.

• Provides guidance and mentorship to less experienced staff and onboards consulting staff, as necessary.

• Identifies, advocates for, and drives opportunities for continuous improvement.

• Responds to inquiries from audits and inspections from world health authorities.

• Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.

Qualifications and Education Requirements

• Knowledge of science generally attained through studies resulting in a Bachelor’s Degree in a scientific or engineering discipline or its equivalent.

• A minimum of 6 years experience in an environment governed by cGMPs, including at least 3 years of computer system validation experience, or equivalent expertise.

• Knowledge of cGMP and regulatory requirements for validation of computerized systems and processes.

• Firm understanding of quality systems

• Proficiency in the use of computers and software applications including electronic change control systems

• Experience with validation of electronic batch records and process automation systems such as Syncade and DeltaV

• Demonstrated interpersonal, communication, and motivation skills.

• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking.

• Experience with executing or overseeing execution within electronic validation systems such as ALM and Valgenesis

• Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva Vault is desirable

• Effective written and verbal communication skills

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Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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