Vice President, Quality

Primary Responsibilities

• Oversees all Quality functions for Grifols Therapeutics.
• Ensures that all biological products, which are manufactured or distributed from 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, validation, documentation, maintenance, etc. at the GT facility.

Additional Responsibilities

• Covers activities of various GT departments whenever the recall of released products sold by the company and manufactured at the facility is required.
• Ensures Quality representation at appropriate industry associations by the Quality team in order to stay abreast of industry trends and new regulations in the areas of compliance/quality assurance/control and manufacturing practices.
• Actively participates in site and Grifols BioScience Group (BIG) Committees.
• Assists in establishing GT Quality Policies and Procedures.
• Maintains and updates manuals as necessary.
• Recommends staffing needs and organizes the activities of the various Quality functions for effective and economical operation.
• Provides for the timely and proper testing and release of raw materials, components, and finished products, including new products for clinical trials.
• Makes final decision on discrepant materials and products.
• Prepares as well as approves budgets for Quality's operating and capital expenses.
• Makes final recommendations on major expenditures requested by the GT Quality organization.

Requirements, Knowledge, Skills, and Abilities

• 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.