Job Information
Bristol Myers Sqibb BMS Manager, Quality Assurance Investigations Cell Therapy - Devens MA in Devens, Massachusetts
469354BR
Auto req ID:
469354BR
Company:
Bristol Myers Sqibb BMS
Job Code:
Pharmaceutical Pharmaceutical
Job Description:
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Position Summary
The Manager, Quality Assurance Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines.
Key Responsibilities
Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
Ensure the corrective/ preventive actions are robust and adequately address the root cause.
May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
Drive deployment of effective deviation processes within representative site/function.
Coach employees on aspects of investigations.
Resolve investigational process or system issues.
Ensure appropriate issues are cascaded to global team and liaise with global team on routine basis.
Provide relevant monitoring of functional area deviation metrics.
Champion for culture of quality within the deviation program.
Proactively monitor metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.
Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects.
Support internal and external inspections as required.
May present individual topics during audits as needed.
Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
Support integration of newer team members
Acts as Subject Matter Expert of the root cause analysis and investigations process and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations.
Lead meetings and represent function at cross functional and network meetings.
Position Title:
Manager, Quality Assurance Investigations Cell Therapy - Devens MA
Job Category:
Health/Medical other
Minimum Education Required:
Masters
Certificates/Security Clearances/Other:
City*:
Devens
Additional Qualifications/Responsibilities:
Qualifications & Experience
Specific Knowledge, Skills, Abilities:
Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheet, etc. and ability to learn and work with new software applications.
Demonstrated experience to interpret complex data & results, understand significant problems with multiple variables and critically assess and provide feedback on proposed CAPA.
Demonstrated experience to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
Excellent verbal and technical writing skills with ability to prepare written communications and present 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 and ability to think critically to create innovative solutions.
Education/Experience/ Licenses/Certifications:
Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
6+ years of experience in a regulated industry, preferably with 2+ year of deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Demonstrated experience with electronic system and databases.
Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Devens - MA - US: $100,480 - $121,756
State*:
Massachusetts
Salary Range:
$100,000