Manager, PDQ Non - sterile Quality Operations

Manager, PDQ Non-Sterile Quality Operations

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.

Key Responsibilities

• Reviews, in a timely manner, all batch and test documentation associated with investigational medicinal products (IMPs) and releases those found in compliance into SAP and QMS as applicable.
• Conducts and plans the review and approval of GMP records, data, and other release documentation as needed, intended for the manufacture of investigational medicinal products.
• 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.
• Brings to the attention of the Quality Operations Management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.
• Performs the monitoring program as required.
• Provides reports to Management related to timely CAPA implementation or other issues, as requested.
• Provides guidance to the CMC teams on quality issues.
• Coordinate and author Quality Agreements (Vendor and Collaboration).
• May participate in Vendor/ Contractors Qualification activities and perform quality risk assessments, as assigned.
• Supports site operations during regulatory agency and third-party inspections and internal audits.
• Adherence to BMS core values.

Qualifications & Experience

• Minimum B.S. in related sciences with 2-7 years' experience in the Pharmaceutical or healthcare industry preferably in a technical or quality role and may be combined with other relevant pharmaceutical industry experience.
• Experience within a QA/QC environment is an asset.
• Experience within R&D environment is an asset.
• Experience in the manufacturing of sterile and/ or non-sterile product is an asset.
• Works with minimum of supervision.
• Strong interpersonal and organizational skills.
• Knowledge of GMP operations and regulations.
• Computer literacy: Microsoft Office and SAP environment, Veeva, PDLIMs, and other systems as required (e.g. DeltaV, Pilotclean).

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 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 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.