Site Head of Quality

Mountain View, CA

· New role to the business as it expanded from 100 to 200 people

· Senior Director level experience upper management

· Everything to do with Quality in the Org - QC, Quality Assurance, Regulatory Affairs

· 6 or 7 Directors and Senior Manager direct reports plus indirects

· Highest level of strategic Quality in the business

· Clinical and Commercial experience required

• Change experience from previous organisations

Position Summary

The Site Quality Head is responsible for assuring the quality and compliance of manufacturing, testing and distribution practices at the Mountain View, California USA site. Under a matrix reporting structure this position reports to Global Head of Quality and Regulatory of the Regenerative Medicine Business Sector, with a dotted line reporting relationship to the Site Head.

For Hitachi Chemical Regenerative Medicine Business Sector, Mountain View, the Site Head of Quality will assume these responsibilities.1) Quality Management System, 2) as mandated by regulatory agencies, and 3) per client expectations as set forth in the Quality Agreement.

Essential Functions and Responsibilities

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  • Ensure the Mountain View 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 Mountain View 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 Mountain View 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 Mountain View 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
  
  
  • Bio-Assay (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.
  
  
  
  

Product Security Pharmacist

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  • Provide oversight as the ultimate authority over work related to manufacturing control and quality control.
  
  
  • Receive, review and approve (As the head of the Quality Council) periodic written reports, audits and metrics to ensure consistency of manufacturing processes and validity of product specifications.
  
  
  • Review deviations that impact on product quality and associated CAPA to ensure that mitigations are appropriate and effective.
  
  
  • Provide information and full cooperation to assist Clients in recall events or complaint investigations.
  
  
  
  

Competencies

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  • 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
  
  
  
  

Supervisory Responsibility

This position requires the management of personnel as high as Sr. Manager level.

Qualifications

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  • 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 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
  
  
  
  

Working Environment

The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors and advisory personnel.

Physical Requirements

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and /or move up to 15 pounds and occasionally lift and/or move up to 50 pounds