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Company

Original Job Post

Bristol Myers Squibb · 2 days ago

Manager, Quality Engineering

Devens, MA

Full-time

Hybrid

Senior Level

6+ years exp

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Responsibilities

Review and approve computer systems validation (CSV) lifecycle documentation for manufacturing site systems.

Administer and maintain the site technical review board and IT change management process.

Act as Subject Matter Expert for risk assessments, data integrity assessments, and technical reports.

Perform routine quality review/approval activities for system onboarding and status.

Identify improvement opportunities and drive team continuous improvement goals.

Represent Quality on large projects or technology transfer initiatives.

Support internal and external inspections, participate in corrective and preventative actions.

Maintain compliance with learning plan, act as validation Subject Matter Expert.

Lead meetings, share data/knowledge within and across site and network.

Build and maintain strong relationships with partner functions.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ValidationFDA regulationsEMA regulationsBiopharmaceuticalsCell therapy manufacturingElectronic validation documentation systemsRegulatory guidelinesComputer skillsMS OfficeSoftware applicationsData interpretationQuality risk managementTechnical writingStrategic thinkingWork prioritizationCross-functional collaborationProblem-solvingHard-workingTeamworkLeadershipCommunicationTime-managementCritical-thinkingDecision-makingInnovationManufacturing Execution Systems (MES)SyncadeDelta VSAPLIMS

Required

Bachelor's degree in STEM field preferred or its equivalence.

Over 6 years of experience in a regulated industry, including at least 3 years of experience in validation related experience. (CSV preferred, analytical equipment, equipment qualification). Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Demonstrated experience with electronic validation documentation systems.

Ability to research, understand, interpret and apply internal policies and regulatory guidelines

Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications

Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.

Ability to critically review protocol reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles

Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy

Ability to work in a fast-paced team environment and lead peers through changing priorities.

Ability to think strategically, meet deadlines and support work prioritization

Able to independently work across functional groups and teams to ensure requirements are met.

Ability to motivate and foster a positive team environment

Confident in making decisions, able to anticipate Quality issues and proactively solve problems.

Curious, with the ability to think critically to create innovative solutions.

Preferred

Knowledge of manufacturing execution systems (MES) such as Syncade and distributive control such as Delta V is desirable

Knowledge of business systems such as SAP, LIMS, Maximo, Veeva Vault, and Valgenesis is desirable

Benefits

Health Insurance

Company

Bristol Myers Squibb

Glassdoor

3.8

At Bristol Myers Squibb, we work every day to transform patients’ lives through science.

Founded in 1887

New York, New York, USA

10,001+ employees

http://www.bms.com

H1B Sponsorship

Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2021 (1)