NJ, US
6 hours ago
Manager, QA - Drug Product (Parenteral)

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. 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, QA - Drug Product (Parenteral)Location: New Brunswick, NJ.

Key Responsibilities

Reviews, in a timely manner, all batch and test documentation associated with investigational medicinal products (IMPs), APIs, raw materials and packaging components and releases those found in compliance into SAP and Quality management system as applicable. Responsibilities include the scheduling and planning of work against timelines.Supports in the investigation of non-conformances and quality incidents. Resolves and documents into Quality management system any deviation or problem pertaining to the audit of documents. Conducts appropriate follow-up, as required. Tracks and trends deviation investigations and CAPAs.Rejects APIs, raw materials, packaging components, and bulk products, filled and packaged IMPs that fail compliance to GMP regulations and BMS specifications and requirements.Ensures records relating to the manufacturing / packaging / testing of IMPs are submitted to the documentation center to be maintained in compliance with the record retention schedule as required.Reviews and approves documents related to Quality Systems such as master batch records, validation protocols/reports, change control, or SOP/WI/OIs to support the release function.May conduct GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees, as requested.May participate in Vendor/ Contractors Qualification activities as assigned.Issues reports to the supervisor, as requested.Reviews, in a timely manner, all batch and test documentation associated with investigational medicinal products (IMPs), APIs, raw materials and packaging components and releases those found in compliance into SAP and Quality management system as applicable. Responsibilities include the scheduling and planning of work against timelines.Supports in the investigation of non-conformances and quality incidents. Resolves and documents into Quality management system any deviation or problem pertaining to the audit of documents. Conducts appropriate follow-up, as required. Tracks and trends deviation investigations and CAPAs.Rejects APIs, raw materials, packaging components, and bulk products, filled and packaged IMPs that fail compliance to GMP regulations and BMS specifications and requirements.Ensures records relating to the manufacturing / packaging / testing of IMPs are submitted to the documentation center to be maintained in compliance with the record retention schedule as required.Reviews and approves documents related to Quality Systems such as master batch records, validation protocols/reports, change control, or SOP/WI/OIs to support the release function.May conduct GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees, as requested.May participate in Vendor/ Contractors Qualification activities as assigned.Issues reports to the supervisor, as requested.Supports management in monitoring document tracking and manpower resource allocations.Reviews procedural documents, as requested.Coordinates scheduling/review of records as requested.Participates in the monitoring program for product quality checks, media fills  and visual inspection program as applicable.Support internal and/or external audits as required.Performs other tasks as requested by the supervisor.Authorized Person, responsible for the release of Investigational Medicinal Products in accordance with the requirements laid down in the Australian Government Therapeutic Goods Administration Guidance on Release for Supply.Adherence to BMS core behaviors. (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Qualifications & Experience

 Specialist: A M.S. with 4-6 years of relevant experience within the pharmaceutical or healthcare industry, or a B.S. with 7-9 years of relevant experience within the pharmaceutical or healthcare industry; including 2-4 years experience in a regulated function.Experience in a R&D environment is an asset.Strong knowledge of pharmaceutical processing techniques.In-depth knowledge of GMP regulations.Strong interpersonal and organizational skills.Demonstrated leadership skills.Computer literacy: Microsoft Office and SAP environment Quality management system, Veeva, PDLIMS, and other systems as required (e.g. DeltaV, PilotClean).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. Provides clear direction and priorities.Works with a minimum of supervision.QA Manager acts as authorized delegate in the absence of the Quality Operations Senior Manager.Travel Required (nature and frequency)Travel may be required for this position and is anticipated to be approximately 10% of the time.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

If you come across a role that intrigues you but does not 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.

if you come across a role that intrigues you but does not 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.

The starting compensation for this job is a range from $93,910.00 USD USD to $121,528.00 USD plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

#BMSBL, BMSBLDMA

#LI-Hybrid

“GPS_2025”

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:

New Brunswick - NJ - US: $93,910 - $113,794

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 a supportive culture, promoting global participation 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 an 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/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.

Confirmar seu email: Enviar Email