Manager, Quality Control Drug Product & Incoming Material -2nd Shift

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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.

Position Summary

In this role you will share oversight of Quality Control (QC) activities related to Drug Product and Incoming Material to ensure compliance with internal policies, procedures, and regulatory requirements. This position will provide support for design, execution, troubleshooting and monitoring of QC process and testing activities pertaining to raw material (including sampling), stability, in-process, and bulk product. You will be responsible for cGMP compliance of the laboratory area and operations under your responsibility as well as for applying and ensuring staff complies with Environmental Health & Safety applicable procedures. This position reports to the Associate Director Quality Control Drug Product and Incoming Material and will be require to work during a 2nd shift (Monday to Friday,14h00 to 22h30 hrs.)

Key Responsibilities

Manage team and ensures cGMP compliance of the laboratory area and operations under responsibility.

• Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met.
• Manages performance and provides technical guidance, coaching and support to team members.
• Assigns training requirements and monitors training status of assigned team members.
• Create team plans to ensure resources are properly allocated and utilized effectively.
• Ensures all equipment used for GMP testing is in a qualified state.
• Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports.
• Support and sustains Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness.
• Actively participates in inspections by Health Authorities.
• Report metrics to monitor schedule progress and help identify risk areas.
• Supports budget definition and adherence to budget target.
• Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in timely manner.
  
  

Oversee QC incoming material, stability, in-process and bulk product testing activities.

• Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress against schedule.
• Ensure timely completion of stability samples in compliant with company procedures.
• Review and approve documentation as required by laboratory procedures.
• Perform final approval and disposition of QC results.
• Provide technical support to QC team members.
• Ensure compendial compliance of excipients (USP, Ph. Eur., JP and JPE as applicable) and evaluates any non-compendial supplier test methods against in-house methods and specifications.
• Defines incoming testing requirements of Incoming Materials, including specifications.
• Oversee sampling plan and testing regimes for all Incoming Materials.
• Provides oversight of testing contracted to external laboratories.
• Represents QC in cross-functional teams supporting New Product Introductions, Qualification and Risk Assessments.
  
  

Support Deviations, Investigations and Change Control Management

• Ensures Deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implement changes in controlled documents.
• Own or lead investigations in collaboration with internal and external functions, as required.
• Approve laboratory investigations, checklists, and deviations as SME/Area Manager.
• Work with impacted QC area functions to define appropriate and effective corrective and preventive actions (CAPAs).
• Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures.
  
  

Promotes safe practices and behaviors.

• Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to prevent similar accidents in the future.
• Ensures that staff (including short duration and temporary contracts) is properly informed on hazards and trained to act in consequence.
• Promotes safe practices and behaviors, assure that EHS requirements are implemented and respected.
• Demonstrate Bristol Myers Squibb values.
  
  

Performs other tasks as assigned.

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

Physical 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 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.