Senior Specialist, QA Technical Operations

Bristol-Myers Squibb Co; Cruiserath; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Pension contribution

Family medical allowance

27 days annual leave

Life assurance

On-site gym

Zusammenfassung

Bristol Myers Squibb Cruiserath Biologics is seeking a Senior Specialist, QA Technical Operations, Drug Substance, for a 12-month fixed-term contract. You will report to the Senior Manager, QA Technical Operations, Drug Substance, and support investigations within MPCC and related areas, plus qualification, validation, NPI and tech transfer projects.

You will also back QA for site validation, change controls, and manufacturing execution systems (SAP, Maximo, MES), driving continuous improvement

Qualifikationen

• BSc in Science or related discipline.
• Minimum 3 years Quality or related experience in biopharmaceuticals.
• Understanding of cGMP requirements and deviation/change management.
• Ability to work independently and within a matrix team.
• Strong communication and organizational skills.

Aufgaben

• Review and approve investigations within MPCC and related areas.
• Triage investigations and lead daily investigations meetings.
• Author, review, and approve QA procedures and documents.
• Support site initiatives to prevent deviation recurrence.
• Promote Right First Time (RFT) in investigations KPI.
• Provide QA support for change controls, NPI and tech transfers.
• Support SAP, Maximo, MES related activities and ALM.

Kenntnisse

Communication skills

Presentation skills

Time management

Organizational skills

Cross-functional collaboration

Problem solving

Initiative

cGMP knowledge

Deviation & change management

Quality systems knowledge

Ausbildung

BSc in Science or related discipline

Tools

SAP

Maximo

MES

Jobbeschreibung

At Bristol Myers Squibb, our employees often ask, "Who are you working for?" - a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Senior specialist, QA Technical Operations, Drug Substance. This is a 12 month fixed term contract role. Reporting to the Senior Manager, QA Technical Operations, Drug Substance, the Senior specialist will support investigations within the Multi Product Cell Culture (MPCC) and supporting areas. The Senior specialist, QA Technical Operations will also be responsible for supporting qualification and validation activities, as well as New Product Introductions (NPI) and technical transfers. The role will support Engineering, Warehouse, Facilities, Utilities and Automation activities while also providing support for SAP, Maximo and Manufacturing Execution System (MES). The role will be both challenging & rewarding and will ensure that the successful candidate can seize a wide range of development opportunities within BMS.

Key Responsibilities

• Support review and approval of investigations within MPCC and supporting areas.
• Facilitate the investigation triage business process and the daily investigations meeting.
• Author, review, and approval of QA related procedures.
• Support implementation of site initiatives to prevent deviation recurrence.
• Promote Right First Time (RFT) approach within investigations process and drive accountability in meeting site investigation KPI’s.
• Provide QA support for change controls, Projects, NPI and Tech Transfer Projects.
• QA support for Maximo, Service Now, ALM and SAP related activities.
• Provide QA support for site validation and qualification activities.
• QA review and approval of Annual Product Quality Review reports (APQRs) Review and approval of GMP documentation, including validation plans, protocols, reports, SOPs, forms, directives, policies and other validation documentation as required.
• Drive and support a culture of continuous improvement initiatives and safe working practices.

Qualifications & Experience

• BSc in Science or a related discipline, with a minimum of 3 years Quality or related experience in the biopharmaceutical industry.
• A clear understanding of cGMP requirements for areas of responsibility.
• Demonstrated knowledge of deviation and change management processes.
• Required to work on his/her own initiative in addition to working as part of a team.
• Must be capable of working across a team matrix to meet accelerated timelines.
• Capable of positively influencing others to bring resolution to complex issues.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task.
• Demonstrated ability to recognise issues, highlight risks and prioritise workload based on site goals and objectives.
• Employees are expected to display the BMS values and behaviours, which enable them to be successful and perform at their highest level.

Why you should apply

You will help patients in their fight against serious diseases. You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

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 #LI-Hybrid

• competitive salary
• annual bonus
• pension contribution
• family medical allowance
• 27 days of annual leave
• life assurance
• on-site gym

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1608411 : Senior Specialist, QA Technical Operations Data Privacy Link

We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.