Quality Control Manager- Chemistry Lab

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. Read more: careers.bms.com/working-with-us .

In this role you will share oversight of Quality Control (QC) testing activities pertaining to stability, in-process, bulk product and Raw Material. In addition, to ensure compliance with internal policies, procedures, and regulatory requirements. This position will be responsible for cGMP compliance of the laboratory area and operations under your responsibility as well as for applying and ensuring staff comply with Environmental Health & Safety applicable procedures.This position will require you to work hours covering part of the 1st and 2nd shifts

Key Responsibilities
Manage team and ensure 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 the training status of assigned team members.
• Support creation of 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 sustain 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 targets.
• Support purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in a 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 on schedule.
• Ensure timely completion of stability samples compliant with company procedures.
• Review and approve documentation as required by laboratory procedures.
• Perform final approval and disposition of QC results.
• Provides oversight of testing contracted to external laboratories.
• Represents QC in cross-functional teams supporting New Product Introductions, Qualification and Risk Assessments, as required.

Support Deviations, Investigations and Change Control Management

• Ensures Deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implements 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 the 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) are properly informed of hazards and trained to act.
• Promotes safe practices and behaviors, ensuring that EHS requirements are implemented and respected.
• Demonstrate Bristol Myers Squibb values.

Performs other tasks as assigned.

Qualifications & Experience

Education and Experience

• BS or advanced degree in Chemistry, 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). Preferably in an Oral Solid Drug manufacturing facility.
• 3-4 years Quality Control Laboratory management experience preferred.
• Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques).
• 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 and SAP preferred.

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 Pharmacopeias requirements applicable to solid oral dose forms.
• Knowledge of Data Integrity and Good Documentation Practices.
• Work to improve efficiency 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 a supportive culture, promoting global participation 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

BMS has an 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 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.

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: https://careers.bms.com/california-residents/

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