Manager, QA Operations
vor 2 Wochen
**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.
The core mission is to ensure all quality aspects related to manufacturing activities are efficiently and timely managed in compliance with BMS Global Processes and Policies, Standard Operating Procedures, and GMP requirements & regulations.
As part of QA Operations, you will act as a key player of the site governance thanks to escalation trough the tier meetings processes, drives performance in his/her scope of responsibilities and actively contributes to continuous improvement initiative.
You will be responsible to address the quality topics, take appropriate decisions at the right level. This position is key to facilitate problems resolution in the organization.
In this position, you will also support quality on the floor for manufacturing, packaging, warehousing and QC as well as maintenance and calibrations activities, in collaboration with all team members from partner department. As part of the quality on the floor organization, a capability to solve issues on call is required (following operation schedule in two shifts). The team works closely with the QA Operations release team to achieve the site objective and release the products on time.
The Manager is accountable to identify from quality standpoint challenges, risks, delays and is skilled to efficiently report and communicate to Senior Management.
The activities include responsibility for execution of the main following processes: deviation and CAPA, change control handling, QA oversight of validation and qualification activities, projects representative and process optimization. Additional tasks are batch record review, risk assessments, as well as the support of health authorities’ inspections and corporate audits.
**COMPETENCIES**:
- Bachelor’s / Master’s degree in Pharmacy, Chemistry, Biology or equivalent degree/experience in a relevant discipline.
- At least 5 years Quality (QA/QC/Compliance) experience in a pharmaceutical/ Biotechnological company. Experience with quality management system operation and improvement.
- Proven leadership skills: empowerment, problem solving, active listener, solution oriented.
- Proven ability to coach other team members and provide guidance.
- Works independently, authority to make decisions.
- Excellent interpersonal, collaborative and organizational skills.
- Excellent communication skills. Ability to communicate (French and English) effectively throughout the organization, internally and externally, with the teams, peers and upper management.
- Very good understanding of solid oral dosage forms manufacturing, packaging, testing, QC, warehousing and validation is preferred.
- Excellent investigational skills and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for resolution.
- Ability to drive continuous improvement and risk management approach in issue resolution and projects.
- Experience in clinical trial data and batch release process is a plus
**Duties and Responsibilities**
**Q**uality oversight of manufacturing, testing and warehousing operations**
- Supports operations in the daily activity and promotes good manufacturing practices, quality culture and right first-time mindset on the shop floor. Take appropriate decisions in collaboration with partner departments to ensure compliance and efficiency of operations activities.
- Responsible for quality oversight on the deviation, lab investigation, CAPA, change control, validation and qualification activities related to production, packaging, testing and warehousing activities.
- Ensure thorough investigations, CAPA definition, change control assessment, validation approach considering right first time and risk-based approach, in a timely manner.
- Oversees maintenance interventions on equipment to ensure cGMP compliance of production and testing processes.
- Manages complex tasks, involvement in cross-functional topics including other BMS entities and Corporate.
- Perform batch record review and prepare batch release documentation, on demand to support the batch release team.
- Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.
**Leadership**
- Provides adequate coaching and guidance in a matrix environment to ensure team’s members fulfil high quality standard and oversight.
- Ability to influence and motivate positively
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