Our leading global, biotechnology client is seeking a Site Head of Quality who will be responsible for assuring the quality and compliance of manufacturing, testing and distribution practices at the Allendale, NJ site. Under a matrix reporting structure this position reports to Global Head of Quality and Regulatory, with a dotted line reporting relationship to the Site Head. 

• 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 audits and ensure audit responses are prepared in a timely manner and aligned with Global Quality and Regulatory prior to 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.
• Direct Reports: Leader of Quality Operations, Leader of Quality Systems, Leader of Quality Control. 

REQUIREMENTS 

• Degree in biological sciences, engineering, or science equivalent.
• 10+ 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 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 manufacturing of 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
• 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)
• The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors, and advisory personnel.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey.

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