Quality Recruiting. Established Experts.

Director/VP of Quality

Reference Number: 2813
Location: Northeast

Our client is a clinical stage biopharmaceutical company developing novel oncology therapeutics.  They have asked us to assist them in their search for a Director/VP of Quality.

The Director/VP of Quality will lead all aspects of Quality Assurance and Quality Control across the Company portfolio, with an emphasis on compliance with GMP, GLP, GCP and GDP requirements and standards.  The position reports to the CEO, and will partner with senior management to develop and maintain the organization’s Quality Plan, and to ensure that internal and external processes and products meet the established standards of quality.

Major tasks and responsibilities will include:

  • Develops Quality Plan and implements quality assurance policies and procedures.  Ensures GxP policies and SOPs are kept current.
  • Monitors Health Authority requirements to interpret and implement quality assurance standards and assure compliance with global standards as they evolve.
  • Establishes and monitors corporate training requirements and maintains training records for all GxP employees.
  • Conducts internal audits of Company processes, systems and documentation to ensure compliance with corporate standards.
  • Supports vendor selection activities by providing timely assessments of Quality Systems and capabilities, and highlighting potential risk factors.
  • Establishes and maintains third party quality standards, including establishment of quality standards for third party deliverables (materials, data and documentation), negotiation and execution of Quality Agreements with GxP suppliers, and planning and execution of third party audits to ensure ongoing compliance with all client quality obligations and current GxP standards.
  • Supports disposition of clinical trial materials, including review and approval of executed batch records and oversight of material inspection and analysis.
  • Monitors product and process performance via the collection and analysis of statistical quality data.  Establishes key Company Quality Metrics.  Analyzes data to identify areas for improvement in internal and external quality systems.
  • Maintains quality documentation and QMS.  Maintains Change Control system and establishes metrics to monitor effectiveness.  Maintains deviation system, monitors CAPA implementation and trend effectiveness.
  • Monitors the effectiveness of processes and quality of work.  Anticipates program and project needs, and continually searches for ways to improve quality delivery.
  • Supports Health Authority submissions via the review of IND and BLA/NDA submissions and corresponding documentation in other regions.

We seek candidates with the following qualifications:

  • BS in a related field is required.
  • At least 10+ years of increasing responsibility in Quality Management at a pharmaceutical or biotechnology company.
  • Established experience working with the US FDA and comparable international regulatory authorities.
  • Experience working with CMOs and CROs, with a detailed understanding of the overall audit process and ongoing vendor quality management.
  • Oncology experience is preferred.
  • The position requires a highly motivated strategic thinker who is able to support cross-functional collaboration in a highly dynamic environment while maintaining required levels of quality, compliance and ethical conduct.
  • Requires approximately 25% travel.  Some international travel may be required.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2813. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.