Transform Your Career with a Challenging Role in Quality Control
Bristol Myers Squibb is known for pushing the boundaries of what's possible in the pharmaceutical industry. As a Quality Control Manager – Microbiology, you'll be part of a team that's constantly striving to innovate and improve processes. With a strong focus on compliance, quality, and safety, this role offers the perfect blend of challenge and reward.
The successful candidate will have a deep understanding of cGMP regulations and their application in solid oral dosage forms. With a minimum of 5 years' experience in a GMP environment, preferably in Quality Control Laboratory management, you'll bring a wealth of knowledge and expertise to the table. Exceptional scientific and practical knowledge of analytical techniques, environmental monitoring testing, and laboratory information management systems are essential requirements for this role.
About the Role
* This is an opportunity to work in a dynamic environment where collaboration and teamwork are highly valued.
* You'll be responsible for overseeing Quality Control activities related to Drug Product and Incoming Material, ensuring compliance with internal policies, procedures, and regulatory requirements.
* The position involves supporting design, execution, troubleshooting, and monitoring of QC processes and testing activities, including sampling, stability, in-process, and bulk product testing.
* Additionally, you'll be responsible for ensuring cGMP compliance of the laboratory area and operations under your responsibility.
Key Responsibilities
* Manage team performance and provide technical guidance, coaching, and support to ensure cGMP compliance.
* Create a positive and collaborative team environment, promoting Bristol Myers Squibb standards.
* Assign training requirements and monitor training status of assigned team members.
* Develop team plans to allocate resources effectively and utilize them efficiently.
* Ensure all equipment used for GMP testing is qualified and maintained.
* Author, review, and approve complex GMP documentation, such as laboratory procedures, work practices, plans, protocols, and reports.
* Support Lean Lab initiatives, including 5S, deviation reduction, Right First Time, and inspection readiness.
* Actively participate in Health Authority inspections.
* Report metrics to monitor schedule progress and identify risk areas.
* Support budget definition and adherence to budget targets.
Requirements
* A Bachelor's or advanced degree in Microbiology, Biochemistry, Pharmacy, or a relevant scientific discipline, or an equivalent combination of education, training, and experience.
* A minimum of 5 years of work experience in a GMP environment (pharmaceutical industry or similar field).
* 1-3 years of Quality Control Laboratory management experience is preferred.
* Exceptional scientific and practical knowledge of analytical techniques, environmental monitoring testing, and laboratory information management systems.
* 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 participating in regulatory inspections.
Competencies
* 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.
Qualifications & Experience
At Bristol Myers Squibb, we value our employees' unique perspectives and talents. If you're a motivated individual with a passion for Quality Control and a drive to succeed, we encourage you to explore this exciting opportunity.
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