Vice President, Quality

Grifols

Vice President of Quality managing all quality assurance and regulatory compliance for Grifols Therapeutics. Leading Quality functions to ensure compliance with international standards and regulations.

Posted 5/26/2026full-timeClayton • North Carolina • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Oversees all Quality functions for Grifols Therapeutics.
Ensures that all biological products, which are manufactured or distributed any GT location, are manufactured and tested in compliance with company specifications and regulatory requirements.
Directs the establishment of Quality policies, systems, procedures and specifications for raw materials, in-process product, and finished products.
Establishes Quality systems and practices to assure compliance with state-of-the-art standards, current GMP regulations (domestic and international) and corporate requirements.
Directs analytical method validations and QC execution to assure that appropriate information is collected, specifications developed, and methods established to assure the approval of IND/NDA's for all biotech compounds researched at GT or any other licenser that will be manufactured.
Directs Quality activities to insure that clinical supplies meet FDA requirements for Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) that are being used by Grifols clinical investigators to receive approved IND/NDA's on compounds to be marketed.
Participates in the technical review process and approves all new or modified products to be manufactured by GT before submission to the FDA for approval and/or release to the market.
Approves all Quality and Manufacturing procedures to ensure that all phases of operations conform to current GMP regulations.
Assures that contract manufacturers of GT are in compliance with appropriate manufacturing practices and that product contract manufacturers meet the desired quality attributes as verified in GT laboratories.
Responsible for the establishment of appropriate quality policies, standards, and practices for manufacturing, warehousing, testing, training, release, valiation, documentation, maintenance, etc. at the GT facility.

Requirements

What you’ll need

Requires a Ph.D. plus 15 years experience, or an equivalent combination of education and experience.
Advanced college degree level knowledge in chemistry, biology, and/or microbiology is required, or equivalent experience, to perform at a decision making level for Grifols Therapeutics. (MS plus 18 years)
A basic understanding of immunology, virology, physical inspection techniques including quality engineering principles and statistical methodology is required.
In each of the major scientific disciplines above, incumbent must be sufficiently knowledgeable to direct staff at various levels in product or process problem-solving and analytical method development in all technical specialties.
Incumbent must possess excellent people skills in order to influence, motivate, teach and encourage his/her direct staff as well as his/her peers to understand and accept his/her recommendations, especially with borderline issues.
Excellent delegation skills to oversee and lead an organization of over 300 quality employees is also required.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

analytical method validationquality control (QC)Good Laboratory Practices (GLP)Good Manufacturing Practices (GMP)quality engineering principlesstatistical methodologybiotechnologyproduct problem-solvinganalytical method developmentbiological product testing

Soft Skills

people skillsinfluencemotivationteachingencouragementdelegationleadershipcommunicationteam managementdecision making

Certifications

Ph.D.MS in chemistry, biology, or microbiology