Quality Manager

Role Summary

Quality Manager responsible for product development for new product supporting IND filing through the BLA filing. Product scope includes cell therapy products and gene therapy products. Support compliance during development, manufacturing, analytical testing and tech transfer. Performing batch release activities and managing deviations and escalations related to the product. Location: East Hanover NJ, Hybrid.

Responsibilities

• Write review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Support Project management functions as a project team member.
• Provide support to TRD line functions in GMP related topics as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).

Qualifications

• Bachelor‚Äôs Degree and at least 10 years‚Äô pharma quality or pharma operations
• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/manufacturing and control.
• Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Good experience in technical drug development as well as in Quality Assurance and Quality compliance departments.
• Experience in Technical Operations or equivalent experience is preferred.
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
• Computer literacy demonstrated along with readiness to learn new systems and associated processes.
• Excellent organizational and project management as well digitalization skills.
• Ability to influence people, negotiate and communicate.