QA Lab Operations Manager, Sterile Drug Product Start-Up

Bristol-Myers Squibb Co; Cruiserath; On-site; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Job summary

BMS Cruiserath Biologics is recruiting a Manager, QA Laboratory Operations for Sterile Drug Product to support startup of a commercial SDP facility and later oversee routine testing and release. The role reports to the Senior Manager and involves QA oversight, method transfer, and equipment qualification, with emphasis on continuous improvement and regulatory readiness.

Qualifications include a science degree with at least 5 years in biopharma, knowledge of EU/FDA regs and cGMP; strong

Qualifications

• Bachelor or Masters in Science or related discipline with a minimum of 5 years’ experience in Biopharmaceutical/Pharmaceutical industry.
• Detailed knowledge of Sterile Drug Product and regulatory requirements including EU, FDA and other regulations.
• Strong technical aptitude, global regulatory experience and experience interfacing with regulators.
• Understanding of cGMP requirements for laboratory compliance including equipment, instrumentation and method qualification.
• Ability to work on own initiative and in a team; strong communication and mentoring skills.

Responsibilities

• Provide QA oversight to start up activities, GMP readiness, Method Transfer and Equipment Qualification; approve SOPs, deviations, CAPAs, change controls, risk assessments, and qualification documentation.
• Coach and develop staff; lead QA oversight of QC start up activities during startup at Cruiserath.
• Collaborate with CQV and QC teams on GMP scope for sterile drug product operations.
• Drive Operational Excellence initiatives (5S, Std Work, Kaizen, Problem Solving); support Self-Inspection program.

Job description

BMS Cruiserath Biologics is recruiting a Manager, QA Laboratory Operations for Sterile Drug Product to support startup of a commercial SDP facility and later oversee routine testing and release. The role reports to the Senior Manager and involves QA oversight, method transfer, and equipment qualification, with emphasis on continuous improvement and regulatory readiness.

Qualifications include a science degree with at least 5 years in biopharma, knowledge of EU/FDA regs and cGMP; strong