Our client is a pharmaceutical company. They have asked us to assist them in a search for a Director, Clinical Quality Assurance  

Major tasks and responsibilities include:

• Develops and maintains GCP compliance programs for clinical studies and future product registration.
• Provides GCP Quality Assurance oversight of vendors and maintains quality agreements.
• Develops and oversees execution of GLP audit programs including CSP’s that conduct various study types including Bioanalytical, Toxicology Studies, Carcogenicity Studies, and Tissue Distribution Studies.
• Supports the development of GCP and GLP Standard Operating Procedures.
• Ensures training programs throughout the company to meet GCP, GLP, and ICH requirements.
• Oversees compliance GCP and GLP auditing programs to fulfill global regulatory requirements.
• Provides expertise and guidance to multiple departments in interpreting and implementing governmental and agency GCP and GLP guidelines to assure compliance.
• Follows applicable regulations including FDA, ICH, GCP, GLP requirements as well as companywide policies and procedures.
• Ensures that direct reports and consultants have completed the training necessary for their assigned responsibilities.
• Represents QA at Clinical project team meetings.

  We seek candidates with the following qualifications:

• A Bachelor’s degree in a scientific or technical related field is required, an Advanced degree is preferred.
• Requires a minimum of 10 years of experience in Quality Assurance within the pharmaceutical, biologics, or other related industries.
• Must have experience with inspections and audits in support of regulatory filings.
• A demonstrable understanding of industry practices, as well as GCP and GLP regulations and practices is required.
• Requires experience implementing Quality Systems in a regulated environment.
• Must have strong organization and time management skills.
• Attention to detail with an ability to perform critical review of various types of documents is required.
• Requires outstanding communication skills, both oral and written.
• Must have the ability to independently solve problems and work cross-culturally.
• The demonstrated ability to work as a team player with multi-disciplinary project teams is required.
• Must demonstrate proficiency with commonly used word processing, database systems, document management, electronic quality systems, virtual communication, cloud-based tools, and other software.

   

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.