Manager, QA Operations
Vor 4 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.
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.
Job Summary
This role is part of the 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 responsible for the execution of the main quality processes such 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 participate in cross-functional projects to support the release, like new product introduction (clinical and commercial), launches, integration projects, etc.
Additionally, you may be assigned tasks such as risk assessments completion/review, support of health authorities’ inspections and Corporate audits, and lead internal audits. You will support 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 initiatives, 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 are a mandatory aspect. The Manager, QA Operations acts as a backup for the Senior Manager, QA Operations, release team.
Duties/Responsibilities
- 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.
- Drive continuous improvement of batch record review, disposition process, and Master Data review in the manufacturing execution system and ERP.
- Contribute to risk assessments, e.g., related to quality issues or projects like new product introduction.
- Provide coaching and guidance to less senior personnel in the QA Operations team.
Compliance
- Identify process quality and cGMP compliance-related issues, interpret the situation, and articulate recommendations through efficient communication.
- Support health authority’s inspections and corporate audits by assisting the QA Compliance team in the preparation of inspections and audits. Act as SME within his/her scope of responsibilities.
- Write SOPs and make recommendations for SOP revisions at a local and global level.
- Approve procedures and documents as SME and as part of the QA approver group.
- Ensure 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, with the 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.
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