Senior Manager, QA Manufacturing Operations
Senior Manager, QA Manufacturing Operations
Apply locations Cruiserath - IE time type Full time posted on Posted Yesterday job requisition id R1587297
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.
The Role
BMS Cruiserath Biologics is seeking to recruit a Senior Manager to support the QA Manufacturing Operations department at Cruiserath for an initial 12-month period.
Reporting to the Associate Director, QA Operations for Biological Drug Substance Manufacture, the QA MFG Ops Senior Manager will be responsible for managing the QA Team responsible for directly supporting commercial drug substance manufacture at BMS Cruiserath.
Key Duties and Responsibilities
1. Managing the Days and Shift Teams providing direct on-the-floor support to Manufacturing Operations
2. Hiring, capacity planning and managing team members to provide quality assurance oversight of Manufacturing Operations and the WCL (Warehouse Cryogenics Logistics)
3. Coordinating the batch record review process in line with disposition cycle times and quality metrics
4. Providing quality support to MS&T (Manufacturing Sciences & Technology) and Supply Chain
5. Providing support for technical transfers and process validation activities
6. Acting as Quality lead on significant investigations
7. Acting as QA approver on site and global change controls
8. SAP QM (Quality Management) maintenance
9. Providing operational support for MES (Manufacturing Execution System) and the introduction of electronic batch records
10. Coordinating QA Walkthrough programs for MPCC and WCL
11. Supporting Maintenance, Environmental Monitoring and Pest Control programs.
12. Supporting the site through regulatory inspections, global inspections and market approvals
13. Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and Compliance, to ensure compliance of operational activities to all applicable policies, directives, guidance documents and regulatory requirements
14. Participating in the site self-inspection program by conducting audits of site functions as required
Qualifications Knowledge and Skills required
1. A degree in science, engineering or related discipline is essential along with a minimum of 5 years’ experience in a role within the biopharmaceutical/pharmaceutical industry.
2. Experience acting as a People Manager is desirable but is not essential.
3. Ability to make decisions and align a target audience with the decision taken.
4. Demonstrated proficiency communicating and collaborating at a variety of levels and across divisions.
5. Excellent time management, attention to detail and organisational skills along with a proven ability to multi-task
6. Demonstrated ability to recognise issues, highlight risks and prioritise workload based on schedule requirements.
7. Proven success working well in a team environment with flexibility to react to changing business needs
8. Demonstrated problem solving and project management ability.
Why you should apply
1. You will help patients in their fight against serious diseases
2. You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
3. You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
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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.
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