Manager, QA Engineering
Working with UsChallenging.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But 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 rich in diversity.
Take your career farther than you thought possible.
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.
Read more:
careers.
bms.
com/working-with-us.
Position:
Manager, Quality Assurance EngineeringLocation:
Warren, NJWorking with Us Challenging.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But 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 rich in diversity.
Take your career farther than you thought possible.
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.
Read more:
careers.
bms.
com/working-with-us Position SummaryThis role is responsible for providing quality oversight on technology transfer into and out of the site, process and method understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility.
This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Key ResponsibilitiesQA lead on technology transfer activities (process and analytical):
Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.
Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
Interact and collaborate with cross-functional teams to achieve common goals.
Provide training to QA colleagues on new product manufacturing process and analytical methods, as applicable to ensure clinical production readiness.
Must be knowledgeable on change control process.
Must be knowledgeable on the process and associated methods for the assigned product.
Support Product/Program Lifecycle Management Activities Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
Support regulatory filings and amendments, as applicable (i.
e.
IND, INDa, CTA etc.
) Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
Review media simulation activities to ensure successful execution and documentation.
Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
Ensure procedures are adequate to review and confirm appropriateness of data.
Display Leadership Qualities Create an environment of teamwork, open communication, and a sense of urgency Promote a mindset of continuous improvement, problem solving, and prevention Drive strong collaboration within the site and across the network Build trust and effective relationships with peers and stakeholders Drive improvements to remove inefficiencies, improve quality and optimize productivity.
Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
Qualifications & Experience B.
S.
degree required.
Minimum of six years of experience in the pharmaceutical or related industry.
Equivalent combination of education and experience acceptable.
Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
Must have knowledge of technology transfer for both manufacturing processes and QC methods.
Knowledge of cell therapy manufacturing, flow cytometry and/or PCR is preferred.
Must routinely anticipate, recognize and resolve quality issues with minimal direction from management.
Inform management of proposed solutions on complex issues.
Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions.
Recognizes risk and develops contingency plans.
Negotiates solutions cross-functionally.
Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Work is self-directed.
Must effectively communicate and interact with management and stakeholders with clarity and accuracy.
Understands fundamental scientific problems.
Must have strong quality background.
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.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#LI-OnsiteBMSCARTVETERANIf 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.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Business Process Improvement Change Management Clinical Trials Clinical Works Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But 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 rich in diversity.
Take your career farther than you thought possible.
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.
Read more:
careers.
bms.
com/working-with-us.
Position:
Manager, Quality Assurance EngineeringLocation:
Warren, NJWorking with Us Challenging.
Meaningful.
Life-changing.
Those aren't words that are usually associated with a job.
But 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 rich in diversity.
Take your career farther than you thought possible.
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.
Read more:
careers.
bms.
com/working-with-us Position SummaryThis role is responsible for providing quality oversight on technology transfer into and out of the site, process and method understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility.
This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Key ResponsibilitiesQA lead on technology transfer activities (process and analytical):
Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.
Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
Interact and collaborate with cross-functional teams to achieve common goals.
Provide training to QA colleagues on new product manufacturing process and analytical methods, as applicable to ensure clinical production readiness.
Must be knowledgeable on change control process.
Must be knowledgeable on the process and associated methods for the assigned product.
Support Product/Program Lifecycle Management Activities Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
Support regulatory filings and amendments, as applicable (i.
e.
IND, INDa, CTA etc.
) Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
Review media simulation activities to ensure successful execution and documentation.
Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
Ensure procedures are adequate to review and confirm appropriateness of data.
Display Leadership Qualities Create an environment of teamwork, open communication, and a sense of urgency Promote a mindset of continuous improvement, problem solving, and prevention Drive strong collaboration within the site and across the network Build trust and effective relationships with peers and stakeholders Drive improvements to remove inefficiencies, improve quality and optimize productivity.
Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
Qualifications & Experience B.
S.
degree required.
Minimum of six years of experience in the pharmaceutical or related industry.
Equivalent combination of education and experience acceptable.
Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
Must have knowledge of technology transfer for both manufacturing processes and QC methods.
Knowledge of cell therapy manufacturing, flow cytometry and/or PCR is preferred.
Must routinely anticipate, recognize and resolve quality issues with minimal direction from management.
Inform management of proposed solutions on complex issues.
Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions.
Recognizes risk and develops contingency plans.
Negotiates solutions cross-functionally.
Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Work is self-directed.
Must effectively communicate and interact with management and stakeholders with clarity and accuracy.
Understands fundamental scientific problems.
Must have strong quality background.
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.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#LI-OnsiteBMSCARTVETERANIf 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.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Business Process Improvement Change Management Clinical Trials Clinical Works Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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