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.
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Job Summary
This role is part of QA Operations team, responsible for end-to-end quality of product released on the market. The Manager, QA Operations reports to the Senior Manager, QA Operations, release team. The Manager QA Operations is responsible for quality assurance (QA) involved primarily with the overall batch record review, batch release, raw material release, and Master Data processes, to achieve the site objectives and release product on time. You will be is responsible for the execution of the main quality processes as deviations (initiation, ownership, approval), CAPAs, change control records handling, Global change control assessments, documentation review and approval.
The Manager, QA Operations is also supporting less senior personnel (“center of competencies”).
You will be participating to cross-functional projects to support the release, like new product introduction (clinical and commercial), launches, integration projects, etc.
Additionally, she/he could be assigned tasks as risk assessments completion/review, support of health authorities’ inspections and Corporate audits, lead of internal audits. You will be supporting the team with product release activities when required.
The Manager, QA Operations is a key player in governance and escalation processes, drives performance in her/his scope of responsibilities, actively contributes to continuous improvement initiative and interacts closely at an above site level with functions like Reg CMC and EU QP team. She/He needs to be capable of handling complex subjects in a cross functional environment, and decision-making skills is a mandatory aspect. The Manager, QA Operations acts as a backup for the Senior Manager, QA Operations, release team.
Duties/Responsibilities
QA Operations
Support the change control process by providing quality change control assessments for both local and global changes, ensuring proper impact evaluation and actions identification. Responsible for change control records within assigned area of responsibility.
Responsible for deviations (ownership and/or approval) and CAPAs definition and completion when related to the QA Operations release team processes.
Support the answer to regulatory requests and any above site function related to the release/disposition processes.
Support the QA Operations release team documentation update to ensure it is up to date and in line with work in progress change controls.
Drives continuous improvement of batch record review, disposition process, and Master Data review in the manufacturing execution system and ERP.
Support the change control process by providing quality change control assessments for both local and global changes, ensuring proper impact evaluation and actions identification. Responsible for change control records within assigned area of responsibility.
Responsible for deviations (ownership and/or approval) and CAPAs definition and completion when related to the QA Operations release team processes.
Support the answer to regulatory requests and any above site function related to the release/disposition processes.
Support the QA Operations release team documentation update to ensure it is up to date and in line with work in progress change controls.
Drives continuous improvement of batch record review, disposition process, and Master Data review in the manufacturing execution system and ERP.
Contributes to risk assessments, e.g., related to quality issues or projects like new product introduction.
Provides coaching and guidance to less senior personnel in QA Operations team.
Compliance
Identifies process quality and cGMP compliance related issues, interprets the situation, and articulates recommendations through efficient communication.
Supports health authority’s inspections and corporate audits by supporting QA Compliance team in the preparation of inspections and audits. Acts as SME within his/her scope of responsibilities.
Writes SOPs and makes recommendations for SOP revisions at a local and global level.
Approves procedures and documents as SME and as part of the QA approver group.
Ensures the representation of QA Operations within department and cross-functional project teams according to assignments.
Qualifications / Experience
Bachelor’s / Master’s degree in Pharmacy, Chemistry, Biology, or equivalent degree/experience in a relevant discipline.
Minimum 6 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance
Thorough understanding of cGMPs and regulatory requirements.
Good understanding of solid oral dosage form manufacturing is preferred.
Excellent interpersonal, collaborative, and organizational skills.
Works independently, authority to make decisions.
Very good communication skills. Ability to communicate (French and English) effectively throughout the organization, internally and externally, with the teams, peers, and upper management.
Excellent problem-solving skills. Ability to interpret complex situations and to articulate recommendations for resolution.
Recognized within the group, provides guidance to other employees.
Ability to drive continuous improvement and risk management approach in issue resolution and projects.
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
BMS 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 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.
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