Manager, Quality Control – Microbiology

Job title:

Manager, Quality Control – Microbiology

Company

Bristol-Myers Squibb

Job description

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: .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.Key ResponsibilitiesManage 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, bulk product testing activities & environmental monitoring 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.

Qualifications & ExperienceEducation and Experience

• BS or advanced degree in Microbiology, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience.
• Minimum 5 years of work experience in a GMP environment (pharmaceutical industry or similar field)
• 1-3 years of Quality Control Laboratory management experience prefer.
• Exceptional scientific and practical knowledge of analytical techniques (e.g., bio burden, identifications, automatic equipment for testing ).
• Exceptional scientific and practical knowledge of environmental monitoring testing
• Experience in executing quality control testing of solid oral dosage forms and raw materials.
• Exceptional knowledge of incoming material sampling and inspection.
• Working knowledge of relevant US, EU. and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections.
• Experience with Laboratory Information Management System (LIMS), Learning Management System (LMS) and Enterprise Resource Planning System (ERP).

Required Competencies: Knowledge, Skills, and Abilities

• Subject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and regulations applicable to solid oral dose forms.
• Knowledge of Data Integrity and Good Documentation Practices.
• Ability to accurately understand, follow, interpret, and apply European Pharmacopeia and United States Pharmacopeia requirements and cGMP requirements.
• Exceptional technical writing skills.
• Work to improve efficiencies through process improvements
• Independent, adaptable, and highly motivated.
• Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities.
• Exceptional communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
• Ability to navigate through ambiguity and rapid growth and adapt to change the status quo.
• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
• General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
• Fluent in English or French and professional command (minimum B2 level) of the second language (written and verbal)

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

Expected salary

Location

Boudry, Neuchâtel

Job date

Fri, 04 Apr 2025 03:26:38 GMT

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