Manager, Regulatory Services Lead
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.
The Regulatory Service Lead will provide people leadership to the facility & plant engineering department for GMP cleaning and pest control.
Is an advocate of designing for reliability, maintainability and operability, and other end-to-end processes associated to audit readiness.
Partner with other functions to improve the overall audit readiness of campus.
Duties & Responsibilities Understand and ensure compliance in GMP space Directly interface, both verbally and written, with vendors.
Compliance:
Stay current with all Client, Federal and State regulations/codes, comply with specifications, and ensure standards are met.
Support Quality Assurance to include training, assigning tasks, performance appraisals, conducting investigations, assisting with CAPAs, and monitor procedures to ensure processes are completed in an efficient and safe manner, and within the scope of policies and procedures.
Supplier Performance Management:
Deliver high quality, creative, and cost-effective solutions.
Monitor work requests to trend vendor performance.
Analytical capability:
Analyze trends and utilize data to anticipate and proactively address issues in the environment.
Checks, inspects, and monitors various types of equipment and systems such as temporary devices or permanent devices to ensure we remain in compliance.
Coordinate repairs, overhauls, and maintains of equipment by replacing or suggesting enhancements.
Respond to emergencies and breakdowns by the following:
evaluating equipment or systems problems; identifying problems with systems covered under service contract and informing the appropriate contractor; determining what repairs are necessary and taking corrective action; deciding with Associated Director - Facilities & Plant Utilities or Subject Matter Expert (SME).
Performs related functions such as inspecting operating systems on a regular basis and identifying and reporting faulty equipment, making entries in logs or other records.
Reviewing blueprints, technical manuals, or other specialized material; identifying work-related problems noted by personnel; responding to complaints; interpreting laws and codes and assessing their applicability to plant operations; attending training programs; and setting work or repair priorities.
Records information such as documentation, device readings & data related to required scope.
Plans and oversees strategic, operational, and administrative programs, projects, and/or services of broad significance to the organization within the designated functional area of focus.
Will partner with leadership and represent the organization to governmental agencies, national organizations, and/or the general public; may represent the principal executive at various community and/or business meetings, as assigned.
Bachelor's degree in Engineering, Mathematics, Science or another relevant field is desired but not required; experience in lieu of degree will be considered with minimum of 2-5 years relevant experience working in GMP manufacturing and/or Quality Compliance setting.
Demonstrated proficiency in managing and organize multiple complex technical projects and familiarity with the manufacturing operations of large-scale production facilities as well as GMP experience.
Demonstrated effectiveness in both a team environment and an individual contributor role.
Regulatory experience and safety knowledge (understanding of OSHA requirements) Demonstrated communication, administrative and leadership skills with ability to work well with other departments, and effectively and efficiently lead in a team environment.
Proven ability to manage multiple priorities in a fast-paced environment.
Ability to understand, implement, and monitor regulatory and safety guidelines applicable to the pharmaceutical industry.
Regulatory Services Lead, is in direct contact with the Associate Director, Facilities & Plant Utilties, and other senior leaders within the site.
Contact with all levels of the organization, in particular Manufacturing, Maintenance and Project Engineering.
Will indirectly support request from Health Authorities during inspections to explain Facilities related inquiries, as required.
Work in GxP manufacturing, mechanical & utility area environment, where proper PPE will be required.
This position is self-directed, receiving high-level goals from incumbent's manager.
Receives assignments in the form of objectives, establishes goals and processes to meet objectives.
Will also receive direction from CMMS system for facility maintenance activity.
Work is reviewed by management to measure meeting of objectives and schedules.
Administers company policies that directly affect subordinate employees.
Recommends changes to unit policies, and procedures.
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 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 Administration Auditing Blueprinting Clinical Trials Communication Corrective And Preventive Action (Capa) 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.
The Regulatory Service Lead will provide people leadership to the facility & plant engineering department for GMP cleaning and pest control.
Is an advocate of designing for reliability, maintainability and operability, and other end-to-end processes associated to audit readiness.
Partner with other functions to improve the overall audit readiness of campus.
Duties & Responsibilities Understand and ensure compliance in GMP space Directly interface, both verbally and written, with vendors.
Compliance:
Stay current with all Client, Federal and State regulations/codes, comply with specifications, and ensure standards are met.
Support Quality Assurance to include training, assigning tasks, performance appraisals, conducting investigations, assisting with CAPAs, and monitor procedures to ensure processes are completed in an efficient and safe manner, and within the scope of policies and procedures.
Supplier Performance Management:
Deliver high quality, creative, and cost-effective solutions.
Monitor work requests to trend vendor performance.
Analytical capability:
Analyze trends and utilize data to anticipate and proactively address issues in the environment.
Checks, inspects, and monitors various types of equipment and systems such as temporary devices or permanent devices to ensure we remain in compliance.
Coordinate repairs, overhauls, and maintains of equipment by replacing or suggesting enhancements.
Respond to emergencies and breakdowns by the following:
evaluating equipment or systems problems; identifying problems with systems covered under service contract and informing the appropriate contractor; determining what repairs are necessary and taking corrective action; deciding with Associated Director - Facilities & Plant Utilities or Subject Matter Expert (SME).
Performs related functions such as inspecting operating systems on a regular basis and identifying and reporting faulty equipment, making entries in logs or other records.
Reviewing blueprints, technical manuals, or other specialized material; identifying work-related problems noted by personnel; responding to complaints; interpreting laws and codes and assessing their applicability to plant operations; attending training programs; and setting work or repair priorities.
Records information such as documentation, device readings & data related to required scope.
Plans and oversees strategic, operational, and administrative programs, projects, and/or services of broad significance to the organization within the designated functional area of focus.
Will partner with leadership and represent the organization to governmental agencies, national organizations, and/or the general public; may represent the principal executive at various community and/or business meetings, as assigned.
Bachelor's degree in Engineering, Mathematics, Science or another relevant field is desired but not required; experience in lieu of degree will be considered with minimum of 2-5 years relevant experience working in GMP manufacturing and/or Quality Compliance setting.
Demonstrated proficiency in managing and organize multiple complex technical projects and familiarity with the manufacturing operations of large-scale production facilities as well as GMP experience.
Demonstrated effectiveness in both a team environment and an individual contributor role.
Regulatory experience and safety knowledge (understanding of OSHA requirements) Demonstrated communication, administrative and leadership skills with ability to work well with other departments, and effectively and efficiently lead in a team environment.
Proven ability to manage multiple priorities in a fast-paced environment.
Ability to understand, implement, and monitor regulatory and safety guidelines applicable to the pharmaceutical industry.
Regulatory Services Lead, is in direct contact with the Associate Director, Facilities & Plant Utilties, and other senior leaders within the site.
Contact with all levels of the organization, in particular Manufacturing, Maintenance and Project Engineering.
Will indirectly support request from Health Authorities during inspections to explain Facilities related inquiries, as required.
Work in GxP manufacturing, mechanical & utility area environment, where proper PPE will be required.
This position is self-directed, receiving high-level goals from incumbent's manager.
Receives assignments in the form of objectives, establishes goals and processes to meet objectives.
Will also receive direction from CMMS system for facility maintenance activity.
Work is reviewed by management to measure meeting of objectives and schedules.
Administers company policies that directly affect subordinate employees.
Recommends changes to unit policies, and procedures.
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 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 Administration Auditing Blueprinting Clinical Trials Communication Corrective And Preventive Action (Capa) Estimated Salary: $20 to $28 per hour based on qualifications.
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