Head of Quality Assurance
Our client is a publicly traded biotechnology company focused on developing and commercializing potential blockbuster drugs for a range of conditions with high unmet medical need. They have asked us to assist them in a search for a Head of Quality Assurance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Establishes and leads the quality assurance function and builds the overarching quality strategy for the company to ensure R&D and commercial success is achieved.
- Recommends solutions to complex quality issues and works closely with senior management to resolve significant compliance trends and issues.
- Develops and implements processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
- Manages audit programs against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensures timely resolution of any identified issues.
- Leads FDA or other GMP inspection audits.
- Establishes and maintains phase appropriate GMP compliance for product manufacture, testing, and stability.
- Ensures appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
- Works with CMO’s and technical teams to assess and resolve discrepancies and noncompliance events to ensure the quality of the product through performance of thorough investigations and risk assessments.
- Implements GCP quality assurance programs for global clinical trial execution and reporting.
- Represents quality assurance in company project meetings to ensure adherence to regulatory and compliance requirements.
- Presents corporate quality strategy to the senior management team.
- Reviews and edits quality agreements, provides quality input to project plans, and masters service agreements and statements of work.
- Reviews technical and study reports, CMC sections of regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports as requested for compliance with established standards and regulations.
- Ensures robust planning and execution of documentation for product release.
- Manages the organization’s training program.
- A Bachelor’s degree, Master’s degree or PhD in science, pharmaceutical sciences or related field is required.
- Must have a minimum of 10 years of experience in quality assurance with significant experience in GMP pharmaceutical development, manufacturing, and testing.
- A proven track record of critical thinking and agility is required. This includes the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
- Must have thorough knowledge of all phases of the drug development process with commercial manufacturing experience being of added value.
- Technical knowledge of analytical method qualifications, process validation and establishing product specifications is required.
- Experience with small molecule products with high volume production is preferred.
- Experience with global outsourced manufacturing and testing operations with solid understanding of how to onboard new CMOs is a plus.
- Must have experience in working in compliance with US, EU, and ICH GMP requirements, as well as experience reviewing submission documentation and responses to regulatory inquiries and inspections.
- Excellent oral and written communication skills are required. Fluency in spoken and written French is also an asset.
- Must be proficient in the use of Microsoft Office suite products including Word, Excel, PowerPoint, Outlook, Microsoft Project Management, and the internet.
- Creativity and problem solving abilities are required.
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.
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