QC Director, Analytical Science And Technology (asat)

QC Director – Analytical Science and Technology

Primary Responsibilities and Job Functions:

• Leads and manages the Analytical Science and Technology function:
• Provides strategic guidance for the team with input from Director, Quality Control.
• Builds culture in line with corporate and departmental guidelines.
• Oversees the analytical compliance team including Out of Specifications/Limits (OOS’s/OOL’s), CAPAs and Change Controls, assay transfers. and validation activities, and serves as the subject matter expert of the Quality Control group.
• Liaison between Analytical Development (AD) and Quality Control. 
• Leads the implementation of new methods from AD to Quality Control.
• Oversees and manages the Stability program with support from Quality Control and AD. 
• Serves as technical SME lead for review and approvals of deviations, Out of Specifications, change controls and CAPA’ 
• Schedules projects and coordinates operational support activities.
• Coach, teach, train, and develop employees through 1:1 meetings, performance reviews, and career planning activities. Support recruiting, staffing, hiring, onboarding performance management, promotion, and discipline of team members as appropriate.
• Identify and implement methods 
• Responsible for supporting cGMP compliance of the department and serves as technical lead during interna/external audits.
• Responsible for working on QC responses to audits (both internal and external). 
• Must have experience in writing technical documents and protocols and regulatory filing documents, including IND CMC sections.
• Able to clearly communicate problems and observations with management from other departments.

Secondary Responsibilities and Functions: 

• Lead and direct the safety, quality, and daily activities for the ASAT function.
• Monitor and coach staff to ensure full compliance with GMP and Quality system requirements. Responsible for overall inspection readiness and compliance with quality requirements.
• Adapts departmental plans and priorities to address resource and operational challenges.
• Outstanding communication skills (verbal and written) to collaborate with Senior Management and other internal/external collaborators in a dynamic, highly cross functional environment. 
• Ensure that the ASAT function is in a continuous state of readiness for production and GMP audits. 
• Ability to foster a collegial, collaborative work environment with peers and team members.  
• Perform other duties as required.  

Experience

• Minimum of 8+ years direct experience in the biopharmaceutical industry, with 5 or more years of hands-on biologics/cell/gene therapy experience required.
• A proven track record of successfully hiring, leading, training, and managing teams is required with a minimum of 5 years in a leadership role.
• Prior experience with FDA/regulatory agency inspections desirable. 
• Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills. 
• Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management/stakeholder groups regarding compliance or quality issues. 
• Strong leadership skills specifically the ability to work collaboratively across functions, leading with transparency and respect. The ability to foster trust in building strong relationship across ProKidney and within the function.
• Experience in building high performing teams that deliver results, holding yourself and others accountable. Proven logic and decision-making abilities, critical thinking skills.  
• Familiarity with aseptic practices and cleanroom operations 
• Statistical techniques
• Expert knowledge of cGMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products focusing on analytical methods. 
• Strong knowledge of current industry trends on Quality Control and familiarity with the latest cell based analytical technologies (g. flow-based assays).
• Masters or PhD in Biological Sciences and/or other aligned scientific field preferred