Manager, QA Operations
Vor 5 Tagen
**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.
**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.
**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 organizati
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