Vice President, Quality

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. 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 policies and will interface with senior management, technical departments, customers, suppliers and regulatory agencies on issues and data. Primary Responsibilities Oversee all Quality functions for Grifols Therapeutics. Ensure that all biological products manufactured or distributed at any GT location are produced and tested in compliance with company specifications and regulatory requirements. Direct the establishment of Quality policies, systems, procedures and specifications for raw materials, in‑process product, and finished products. Establish quality systems and practices to assure compliance with state‑of‑the‑art standards, current GMP regulations (domestic and international) and corporate requirements. Direct analytical method validations and QC execution to assure that appropriate information is collected, specifications developed, and methods established to support approval of IND/NDA’s for all biotech compounds researched at GT or by any other licenser that will be manufactured. Direct quality activities to ensure that clinical supplies meet FDA requirements for Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) used by Grifols clinical investigators to receive approved IND/NDA’s on compounds to be marketed. Participate in the technical review process and approve all new or modified products to be manufactured by GT before submission to the FDA for approval and/or release to the market. Approve all Quality and Manufacturing procedures to ensure that all phases of operations conform to current GMP regulations. Assure 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. Establish appropriate quality policies, standards, and practices for manufacturing, warehousing, testing, training, release, validation, documentation, maintenance, etc. at the GT facility. Additional Responsibilities Coordinate activities of various GT departments during recall of released products sold by the company and manufactured at the facility. Represent Quality at appropriate industry associations to stay abreast of industry trends and new regulations in compliance/quality assurance/control and manufacturing practices. Actively participate in site and Grifols BioScience Group (BIG) Committees. Assist in establishing GT Quality Policies and Procedures; maintain and update manuals as necessary. Recommend staffing needs and organize the activities of the various Quality functions for effective and economical operation. Provide for the timely and proper testing and release of raw materials, components, and finished products, including new products for clinical trials. Make final decisions on discrepant materials and products. Prepare and approve budgets for Quality's operating and capital expenses; recommend major expenditures requested by the GT Quality organization. Requirements, Knowledge, Skills, and Abilities Requires a Ph.D. plus 15 years of 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. Scope extends across various and diverse drug products, disposable equipment, plasma and new biotechnology products. 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. Must possess good social ability to work with employees at all levels, excellent people skills to influence, motivate, teach and encourage direct staff and peers, and excellent delegation skills to oversee and lead an organization of over 300 quality employees. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. #J-18808-Ljbffr