What are the responsibilities and job description for the Manager, QA Operations - Warren, NJ position at VetJobs?
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.
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.
The Manager, QA Operations is responsible for quality oversight of Cell Therapy Development Operations activities in accordance with BMS policies, standards, procedures, and Global cGMP requirements. Functional responsibilities include On-Site coverage/participation in QA Shop Floor and Warren Site Walkthrough activities, Label Printing and Issuance of finished drug product and shipping labels, Event Triage including Deviation and CAPA QA Review and Approval, Packout oversight and performing market release, ensuring accurate and timely review and maintenance of clinical manufacturing GMP/batch related documentation and procedures.
This position reports to the Senior Manager of Quality Assurance Operations.
Manages QA Operational Functions and coordinates team activities.
Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products.
Participate in Shop Floor and Warren Site Walkthrough programs.
Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations.
Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints.
Revise department SOPs, as well as Review and QA Approval of CTD SOPs.
Perform Real time review /approval of executed batch records and Chain Of Identity verification.
Responsible for ERP Material Status Changes of production/drug product.
Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
Supports Risk Assessments/projects as required by senior management.
Auto req ID
442261BR
Minimum Education Required
High School/GED
Job_Category
Management
Additional Qualifications/Responsibilities
Qualifications & Experience:
B.S. scientific discipline or relevant college / university degree preferred.
Minimum 7 years cGMP work experience with minimum 5 years of Quality experience.
Equivalent combination of education and experience acceptable.
Strong knowledge of cGMP Quality And Compliance principles required.
Clinical And Phase Appropriate Experience Preferred.
Strong cross-functional collaboration experience required.
Must have advanced knowledge and Quality experience with cGMP manufacturing US and global requirements.
Must possess an independent mindset and have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Work is self-directed yet collaborative with CTD counterparts.
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
Follows established procedures and performs work as assigned and Develops procedures as needed.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Proposes solutions for complex issues and works with management to resolve.
Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy.
City*
Warren
State*
New Jersey
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
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.
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.
The Manager, QA Operations is responsible for quality oversight of Cell Therapy Development Operations activities in accordance with BMS policies, standards, procedures, and Global cGMP requirements. Functional responsibilities include On-Site coverage/participation in QA Shop Floor and Warren Site Walkthrough activities, Label Printing and Issuance of finished drug product and shipping labels, Event Triage including Deviation and CAPA QA Review and Approval, Packout oversight and performing market release, ensuring accurate and timely review and maintenance of clinical manufacturing GMP/batch related documentation and procedures.
This position reports to the Senior Manager of Quality Assurance Operations.
- Note: The work week for this position is Wednesday-Sunday.
Manages QA Operational Functions and coordinates team activities.
Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products.
Participate in Shop Floor and Warren Site Walkthrough programs.
Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations.
Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints.
Revise department SOPs, as well as Review and QA Approval of CTD SOPs.
Perform Real time review /approval of executed batch records and Chain Of Identity verification.
Responsible for ERP Material Status Changes of production/drug product.
Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
Supports Risk Assessments/projects as required by senior management.
Auto req ID
442261BR
Minimum Education Required
High School/GED
Job_Category
Management
Additional Qualifications/Responsibilities
Qualifications & Experience:
B.S. scientific discipline or relevant college / university degree preferred.
Minimum 7 years cGMP work experience with minimum 5 years of Quality experience.
Equivalent combination of education and experience acceptable.
Strong knowledge of cGMP Quality And Compliance principles required.
Clinical And Phase Appropriate Experience Preferred.
Strong cross-functional collaboration experience required.
Must have advanced knowledge and Quality experience with cGMP manufacturing US and global requirements.
Must possess an independent mindset and have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Work is self-directed yet collaborative with CTD counterparts.
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
Follows established procedures and performs work as assigned and Develops procedures as needed.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Proposes solutions for complex issues and works with management to resolve.
Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy.
City*
Warren
State*
New Jersey
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Bristol Myers Sqibb BMS
