Vice President, Quality

Summary:

The Vice President of Quality manages all quality assurance, quality control, and quality compliance functions at the Grifols Therapeutics (GT) site. The VP, Quality will oversee the development of all policies, practices, procedures and specifications applicable to Grifols' products manufactured in accordance with company's policies; and, interface with other members of the senior management team, at their respective sites as well at other Grifols locations, technical departments, customers, suppliers and regulatory agencies in the review of issues and data.

Primary Responsibilities:

• 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.

Additional Responsibilities:

Coordinates 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; Assist 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; and 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. (MS plus 18 years)

A basic understanding of immunology, virology, physical inspection techniques including quality engineering principles and statistical methodology is required. As applicable, the scope extends across various and diverse drug products, disposable equipment, plasma and new biotechnology products.

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. Because of the organizational size and diversified product portfolio and technical structure of the functional area, the incumbent must possess a good social ability to work with employees at all levels (i.e. Technician, Manager, Director, etc.) within the organization. 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.