Manager, Quality Control - Microbiology

switzerland, Switzerland

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: Bristol Myers Squibb
Region: switzerland ,

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.

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 Responsibilities

1. Manage team and ensures cGMP compliance of the laboratory area and operations under responsibility.
2. Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met.
3. Manages performance and provides technical guidance, coaching and support to team members.
4. Assigns training requirements and monitors training status of assigned team members.
5. Create team plans to ensure resources are properly allocated and utilized effectively.
6. Ensures all equipment used for GMP testing is in a qualified state.
7. Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports.
8. Support and sustains Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness.
9. Actively participates in inspections by Health Authorities.
10. Report metrics to monitor schedule progress and help identify risk areas.
11. Supports budget definition and adherence to budget target.
12. 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

1. Collaborate cross-functionally and interdepartmental to define testing priorities, assign work to team members, and monitor progress against schedule.
2. Ensure timely completion of stability samples in compliant with company procedures.
3. Review and approve documentation as required by laboratory procedures.
4. Perform final approval and disposition of QC results.
5. Provide technical support to QC team members.
6. 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.
7. Defines incoming testing requirements of Incoming Materials, including specifications.
8. Oversee sampling plan and testing regimes for all Incoming Materials.
9. Provides oversight of testing contracted to external laboratories.
10. Represents QC in cross-functional teams supporting New Product Introductions, Qualification and Risk Assessments.

Support Deviations, Investigations and Change Control Management

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

Promotes safe practices and behaviors.

1. Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to

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