Manager, External QA, Non-Sterile - Bristol Myers Squibb
New Brunswick, NJ
About the Job
Working 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 .
PURPOSE AND SCOPE OF POSITION:
The position provides Quality oversight for the selection of Contract Manufacturing Organizations (CMOs) used for the manufacture, bulk packaging, testing and distribution of Clinical Supplies in accordance with corporate policies, procedures and GMPs. The incumbent will cover multiple products at the CMOs and will report to the Associate Director, External QA Lead.
DUTIES AND RESPONSIBILITIES
+ Oversees the Contract Manufacturing Organization's Quality Management Systems:
+ Partner with Clinical Supply Operations (CSO) and Drug Product Development (DPD)/Chemical Product Development (CPD) to identify and qualify manufacturing facilities for the Manufacture, Bulk Packaging and testing of API and/or Clinical Drug Products.
+ Serves as the BMS Quality single point of contact for the assigned CMOs with responsibility for Quality and Compliance performance.
+ Ensures Deviations, Product Quality Complaints, Change Controls, Stability and CAPAs are managed in a compliant and timely manner.
+ Oversees vendor change control process and ensures that BMS products are manufactured in full compliance with all applicable regulations.
+ Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status.
+ Partners with CSO / DPD / CPD to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
+ Quality Review and Approval of GMP Documentation:
+ Responsible for final Batch Disposition decisions: Reviews, in a timely manner, all batch and test documentation associated with Active Pharmaceutical Ingredients and/or Investigational Medicinal Products (IMPs) and releases those found in compliance into SAP and QMS as applicable.
+ Conducts, plans, schedules the review and approval of GMP records, data, and other release documentation as needed, intended for the manufacture of API and IMPs.
+ Reviews and approves documents related to Quality Systems such as master batch records, manufacturing and laboratory investigation reports, and other documents as needed.
+ Provides instruction and guidance on quality issues and serves as a resource for the site.
+ Participates in Corporate Vendor Audits/Visits as required.
+ Provides guidance to the CMC QA teams on quality issues.
+ Authors procedural documentation.
+ Coordinates and authors Quality Agreements.
+ Supports site operations during regulatory agency and third-party inspections as required.
+ Performs Vendor Quality Risk Assessments.
+ Performs other tasks as assigned.
EDUCATION AND EXPERIENCE
+ BS/MS in a Scientific discipline, preferably in Chemistry, Pharmacy, 2-5 years' experience in the Pharmaceutical industry in a technical or quality role and may be combined with other relevant Pharmaceutical industry experience.
+ Periods spent in clinical or commercial manufacturing operations would be considered advantageous. Experience within a QA/QC environment is an asset.
+ Experience within R&D, including Chemical Development and/or Drug Product Development environment is an asset.
+ Experience in the manufacturing of non-sterile drug product and drug substance.
+ General knowledge of GMP operations and regulations.
Required knowledge, skills, abilities:
+ Decision-making regarding disposition for distribution of clinical trial materials and materials for production, based on documentation review.
+ Decision-making where commitment is required on release dates for product and/or material.
+ Works to resolve problem that may arise when a product or material needs to be released in a short time frame and documents received are incomplete and/or contain errors.
+ Demonstrates initiative to clarify unclear situation in the presence of documentation irregularities.
+ Prioritizes when handling multiple work assignments and deadlines.
+ Works with minimum of supervision.
+ Strong interpersonal and organizational skills.
+ Demonstrated leadership skills.
+ Effective written and verbal communication.
+ Computer literacy: Microsoft Office and SAP environment, Veeva, PDLIMs, and other systems as required (e.g. DeltaV, Pilotclean).
WORKING CONDITIONS: (US Only) PHYSICAL/MENTAL DEMANDS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.
Approximately up to 10% domestic and/or international travel, as needed.
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™ , 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
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586078
Updated: 2024-10-09 03:41:49.912 UTC
Location: New Brunswick-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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 .
PURPOSE AND SCOPE OF POSITION:
The position provides Quality oversight for the selection of Contract Manufacturing Organizations (CMOs) used for the manufacture, bulk packaging, testing and distribution of Clinical Supplies in accordance with corporate policies, procedures and GMPs. The incumbent will cover multiple products at the CMOs and will report to the Associate Director, External QA Lead.
DUTIES AND RESPONSIBILITIES
+ Oversees the Contract Manufacturing Organization's Quality Management Systems:
+ Partner with Clinical Supply Operations (CSO) and Drug Product Development (DPD)/Chemical Product Development (CPD) to identify and qualify manufacturing facilities for the Manufacture, Bulk Packaging and testing of API and/or Clinical Drug Products.
+ Serves as the BMS Quality single point of contact for the assigned CMOs with responsibility for Quality and Compliance performance.
+ Ensures Deviations, Product Quality Complaints, Change Controls, Stability and CAPAs are managed in a compliant and timely manner.
+ Oversees vendor change control process and ensures that BMS products are manufactured in full compliance with all applicable regulations.
+ Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status.
+ Partners with CSO / DPD / CPD to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
+ Quality Review and Approval of GMP Documentation:
+ Responsible for final Batch Disposition decisions: Reviews, in a timely manner, all batch and test documentation associated with Active Pharmaceutical Ingredients and/or Investigational Medicinal Products (IMPs) and releases those found in compliance into SAP and QMS as applicable.
+ Conducts, plans, schedules the review and approval of GMP records, data, and other release documentation as needed, intended for the manufacture of API and IMPs.
+ Reviews and approves documents related to Quality Systems such as master batch records, manufacturing and laboratory investigation reports, and other documents as needed.
+ Provides instruction and guidance on quality issues and serves as a resource for the site.
+ Participates in Corporate Vendor Audits/Visits as required.
+ Provides guidance to the CMC QA teams on quality issues.
+ Authors procedural documentation.
+ Coordinates and authors Quality Agreements.
+ Supports site operations during regulatory agency and third-party inspections as required.
+ Performs Vendor Quality Risk Assessments.
+ Performs other tasks as assigned.
EDUCATION AND EXPERIENCE
+ BS/MS in a Scientific discipline, preferably in Chemistry, Pharmacy, 2-5 years' experience in the Pharmaceutical industry in a technical or quality role and may be combined with other relevant Pharmaceutical industry experience.
+ Periods spent in clinical or commercial manufacturing operations would be considered advantageous. Experience within a QA/QC environment is an asset.
+ Experience within R&D, including Chemical Development and/or Drug Product Development environment is an asset.
+ Experience in the manufacturing of non-sterile drug product and drug substance.
+ General knowledge of GMP operations and regulations.
Required knowledge, skills, abilities:
+ Decision-making regarding disposition for distribution of clinical trial materials and materials for production, based on documentation review.
+ Decision-making where commitment is required on release dates for product and/or material.
+ Works to resolve problem that may arise when a product or material needs to be released in a short time frame and documents received are incomplete and/or contain errors.
+ Demonstrates initiative to clarify unclear situation in the presence of documentation irregularities.
+ Prioritizes when handling multiple work assignments and deadlines.
+ Works with minimum of supervision.
+ Strong interpersonal and organizational skills.
+ Demonstrated leadership skills.
+ Effective written and verbal communication.
+ Computer literacy: Microsoft Office and SAP environment, Veeva, PDLIMs, and other systems as required (e.g. DeltaV, Pilotclean).
WORKING CONDITIONS: (US Only) PHYSICAL/MENTAL DEMANDS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.
Approximately up to 10% domestic and/or international travel, as needed.
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™ , 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
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1586078
Updated: 2024-10-09 03:41:49.912 UTC
Location: New Brunswick-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb