Senior Manager, Quality Operations Cell Therapy

Job Description

Just as Cell Therapy is redefining personalized medicine, we are creating the industry defining Cell Therapy Operations, for our patients, caregivers, providers and partners. Our global Cell Therapy Development and Operations team’s mission is to define and deliver the world’s most trusted cell therapy manufacturing and distribution network and to install and maintain the highest quality standards.

This key position will provide Quality oversight of Contract Manufacturing Organizations (CMOs) performing key manufacturing steps for CAR-T products in Europe. This professional will take responsibility for keeping the highest quality standards for commercial products as well as for ongoing and future clinical studies. In addition, this role will partner and provide support to the Qualified Person (QP) with respect to drug product disposition and distribution in the EU. The candidate will also be the connection between EU based external partners (manufacturer, distribution center) and US based Celgene (a wholly owned subsidiary of Brystol-Myers Squibb) of sites involved in the complex and fast-growing supply chain of cell therapy products. He/She will partner with different functions to develop and optimize efficient and high-class processes for commercialization of CAR-T products.

Key Responsibilities:

• Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR T) intermediate product manufacturing.
• Partner with CMO Quality to provide oversight of manufacturing operations and ensure work is performed in accordance with approved regulatory submissions, technical agreements and applicable regulatory requirements.
• Responsible for batch record review internal (Celgene) Day 0/Make 1 intermediate disposition.
• Responsible for review and approval of CMO deviation investigations, CAPA, controlled documents (Master records).
• Responsible for review and approval of internal investigations and CAPA affecting the CMO.
• Act as QA impact assessor and approver of CMO related changes.
• Support in data auditing and review of protocol/reports in support of regulatory submissions.
• Develop and approve annual product review reports generated by CMOs.
• Collaborate with Global Quality Systems and ensure CMO’s timely implementation of corrective actions resulted from Celgene’s audits.
• Partner with stakeholders across different operational functions to define projects in order to improve processes and represent the quality organisation in implementation phase.
• Drive, lead and oversee quality related improvement projects in collaboration with affected CMO functions.
• Support in setting and follow up of CMO related key performance indicators (KPI) and metrics.
• Provide Quality oversight of routine operations for EU distribution center responsible for import, disposition and distribution of finished cell therapy product (CAR-T) in EU.
• Partner and provide support to the Qualified Person (QP) with respect to finished drug product release for EU.

Required Qualifications:

• Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.
• Min. 10 years EU GMP regulated industry experience with a minimum of 5 years’ experience in quality assurance, quality control, and compliance.
• Strong organizational skills, including ability to follow assignments through to completion.
• Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions.
• Excellent verbal and written communication skills.
• Ability to work in cross functional teams.
• Fluent in English and German.

Preferred Qualifications:

• Experience within the Cellular Therapeutics environment.
• Experience with Commercial products.
• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.
• Ability to prioritize and successfully manage complex and competing projects.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Ability to work in a fast-paced environment.