Our client is a biotechnology company. They have asked us to assist them in a search for an Executive Director, Quality.  

Major tasks and responsibilities include:

• Sets the strategic direction for the Quality Systems function.
• Establishes and maintains Quality Systems to support GXP activities.
• Enhances and maintains GXP Policies and Procedures to assure regulatory compliance and product quality.
• Evaluates GXP compliances risks and develops and implements risk mitigation measures when necessary.
• Ensures compliant documentation, training, and quality management system processes.
• Provides leadership in preparation for successful regulatory agency inspections.
• Provides long range planning of Quality System related activities.
• Leads Quality initiatives and drive continuous improvement efforts.
• Implements Quality Management Review process, providing KPIs and Quality metrics.
• Evaluates quality and compliance issues and determine corrective actions and need for escalation.
• Acts as a subject matter expert during regulatory inspections of Quality Systems.
• Mentors staff and develops the team.

We seek candidates with the following qualifications:

• A Bachelor’s degree in a scientific discipline is required. A Master’s degree or higher is preferred.
• Must have at least 15 years in the pharmaceutical industry, including at least 10 years in Biotech or Pharma.
• Requires demonstrated record of accomplishments in the life sciences industry expanding from a clinical stage company through to commercialization.
• Must have a thorough working knowledge of Quality Systems to support GXP operations and ensure compliance with GXP regulations.
• The demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance is required.
• Must have experience with procedural document authoring.
• Must be highly proficient in quality management platforms and tools.
• Outstanding communication skills (interpersonal, verbal and written) are required.
• Requires a proven track record of industry successes including experience leading and supporting regulatory inspections.
• Must have exceptional leadership skills working with multiple functional areas in a fast-paced matrixed team environment.

 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.