Experience Level: Director

Experience Required: 10 years

Education Level: Bachelor’s degree

Job Function: Research

Industry: Biotechnology

Relocation Assistance: No

VISA: Only United States Citizens and Green Card Holders

Must-Haves:

• 10+ years’ experience within GMP quality
• 10+ years of managerial experience
• 10+ years of process improvements
• Must come from pharma/biotech/med device/cell therapy/ gene therapy
• Experience managing a team of 10 directors/Sr Managers with an indirect headcount of over 50 employees.
• Honestly, this is the head of quality here in Allendale; they will not accept anyone who is not at least within a director role for 3+ years.
• No Consultants or job hoppy contract candidates

The Site Quality Head is responsible for assuring the quality and compliance of manufacturing, testing, and distribution practices at the Allendale, NJ USA site.

Essential Functions and Responsibilities:

• Ensure the Allendale Site operates in compliance with all applicable Health Authority Regulations and Global Quality and Regulatory Standards.
• Actively participate as a member of the Global Quality and Regulatory Leadership Team.
• Actively participate as a member of the Allendale Site Leadership Team
• Provide oversight and guidance to the Site Quality Operations functions, including but not limited to documentation, deviation, CAPA Change Control, and self-inspection.
• Implement globally aligned quality metrics and be accountable for the performance against targets for the site.
• Participate in the development of Global Quality Standards and Global Operating Procedures and assure full implementation at the Allendale Site
• Support and implement globally selected electronic Quality Management Systems (eQMS) for document management, CAPA management, nonconformance management, training management, change management.
• Support and implement electronic Laboratory Management Systems (LIMS) for Microbiology and Bioassay Laboratories.
• Create and manage Site Quality Governance forums (Site Quality Management Review) and present Allendale performance and actions at Global Management Review meetings.
• Develop, deliver, and monitor a harmonized training curriculum with proficiencies that challenge trainees in
• GMP Training (initial and annual refresher)
• Aseptic behavior and technique
• Cleaning and Sanitization
• Batch Record Review
• Deviation/CAPA and Change Control initiation and completion
• Permanent inspection readiness
• Communicate and partner with other Site Quality Heads to assure harmonization in metrics, methods, processes, and programs related to Quality Systems and applications of applicable Health Authority Regulations.
• Partner with the Site Leadership Team to maintain the facility, processes, and systems in an audit-ready state and propose CAPA where required to mitigate gaps or disconnects.
• Host client and regulatory/compliance audit and ensure audit responses are prepared promptly and aligned with Global Quality and Regulatory before submission.
• Prepare and/or approve Quality Agreements for Clients and critical material vendors based on globally approved templates.
• Provide oversight and guidance to the Quality Control Function
• Bioassay (cell counts, Flow Cytometry, etc.) for in-process and finished products as required
• Microbiology (sterility, endotoxin, Mycoplasma, Environmental Monitoring) as required
• Technical Transfer of Analytical Test Methods
• Accountable to ensure Quality Risk Management principles are appropriately applied and implemented.

Qualifications:

• Degree in biological sciences, engineering, or science equivalent
• Ten or more years as a Quality Assurance, Quality Control, or Compliance Senior Leader in a regulated pharmaceutical company
• Proven ability to lead, coach, and motivate employees, clearly communicate job requirements, and effectively manage the performance of assigned staff
• Working knowledge of routine QC laboratory procedures such as flow cytometry, CBC analysis, endotoxin testing, sterility testing, laboratory instrumentation, and software, environmental monitoring
• Understanding of GMP and GCTP requirements for the manufacturing of the sterile product, the qualification of laboratory instrumentation, and analytical method validation
• Working knowledge of aseptic production processes, supporting technologies, and validation requirements.
• Experience with writing, reviewing, and following Standard Operating Procedures and Work Instructions
• Domestic and some international travel may be required.

Competencies/Candidate Profile:

• Strong leadership skills in both traditional and matrix organizational structures
• Excellent organizational skills and attention to detail
• Excellent verbal and written communication skills
• Strong team-oriented interpersonal skills
• Technical knowledge and root cause analysis skills (problem-solving)