QC Projects Lead, Process Improvement & Training

Bristol-Myers Squibb Co; Dublin; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Job summary

Bristol Myers Squibb (Cruiserath Biologics) in Ireland is seeking a QC Projects Senior Specialist to support the QC Projects team at its Multi-Product Cell Culture Drug Substance and Sterile Drug Product Manufacturing Facility. You will report to the QC Shared Services Projects Senior Manager and help drive continuous improvement across QA/QC processes.

The role involves planning, tracking, and executing projects, supporting training, tech transfers, and compliance with SOPs and regulatory

Qualifications

• Third level qualification (Degree) in Science or related discipline.
• Minimum of 2 years of experience in a pharmaceutical / healthcare laboratory or related technical function.
• Demonstrate excellent written and verbal communication skills and experience of working with teams and influencing decisions.
• A strong knowledge of laboratory operation, in particular training and testing requirements from receipt to CoA is required.
• Involvement in project scoping and tracking is desirable.
• Experience leading cross-functional teams and knowledge of applicable regulatory requirements is desirable.

Responsibilities

• Support the QC teams with continuous improvement projects as part of the QC Projects team portfolio.
• Support process improvements for onboarding, training plans and method specific training.
• Support process improvements for investigation reduction and right first time in the QC teams.
• Support Lean labs and automated scheduling tool process improvements.
• Project management of projects assigned to self, including planning, tracking, communication and escalations where needed.
• Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools.
• Support of operational training activities to support efficiency and compliance across QC e.g support onboarding, delivering training and other training related requests.
• Support of tech transfers managed by the QC Projects team, where needed.
• Perform activities to support Drug Substance release e.g. tracking, data collation, where needed.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Ensure any laboratory process improvements align with the BMS Safety culture.
• Approval of SOPs, Training documents etc., where required.
• Participate in regulatory agency inspections as required.

Skills

Science degree

2+ years pharma lab experience

Regulatory knowledge

Cross-functional leadership

Effective communication

Education

Bachelor's degree in Science or related discipline

Job description

Bristol Myers Squibb (Cruiserath Biologics) in Ireland is seeking a QC Projects Senior Specialist to support the QC Projects team at its Multi-Product Cell Culture Drug Substance and Sterile Drug Product Manufacturing Facility. You will report to the QC Shared Services Projects Senior Manager and help drive continuous improvement across QA/QC processes.

The role involves planning, tracking, and executing projects, supporting training, tech transfers, and compliance with SOPs and regulatory