Head of Quality Assurance
Our client is a biotechnology company. 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 the QA function and creates an overarching, phase-appropriate quality strategy to ensure R&D and commercial success.
- Implements, develops, and executes a quality management system that incorporates all elements of GLP, GCP, and GMP compliance.
- Implements and develops quality assurance standards and processes that improve efficiency and compliance with regulatory guidelines and industry quality standards.
- Manages quality assurance relationships with external manufacturing partners.
- Works closely with GxP functions and senior management to identify and propose solutions to complex quality issues and compliance trends.
- Develops and manages GxP audit plan to ensure FDA/EMA/ICH compliance and oversees inspection readiness activities as the company evolves.
- A Bachelor’s degree, Master’s degree, or PhD in sciences or related field is required.
- Requires a minimum of 15 years of quality assurance experience across GxP functions, with at least five years of experience as a leader of a quality group or function.
- Extensive experience implementing, building, and leading quality assurance groups or functions in the life science industry is required.
- Must have experience with all QA-related facets of developing and commercializing small molecule products.
- Must have excellent communication and people management skills as well as the ability to lead direct reports and collaborate with cross-functional teams.
- Must have a proven track record across GxP functions with an emphasis on GMP pharmaceutical development, manufacturing, and testing.
- Extensive experience developing, maintaining, and improving quality systems and processes is required.
- Must have an advanced understanding of regulatory and industry quality standards and associated processes.
- Experience in hosting and leading FDA and other regulatory authority audits as well as prior oversight of regulatory authority inspection preparedness is preferred.
- A proven track record of partnering with external and internal stakeholders to solve complex operational issues and improve efficiency and compliance is 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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