Quality Assurance Senior Manager

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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.

Grifols seeks a highly motivated Quality Assurance Senior Manager, who will be integrated into the global Plasma R&D QA department to support GigaGen, a subsidiary of Grifols. This position will lead the continued development of GigaGen’s Quality Management System to advance GigaGen’s recombinant monoclonal and polyclonal antibody therapeutic programs from early-stage development through the clinic.

 

Primary Responisbilities for role:

• Oversee the overall non-clinical quality assurance strategy and performance of the organization, mainly focused on GigaGen as a part of the Grifols Plasma R&D QA department
• Ensure compliance with all applicable regulatory standards; is the primary contact with regulatory agencies during audits
• Lead the development, implementation, and maintenance of Grifols’ and GigaGen’s phase appropriate Quality Systems and Policies
• Oversee the execution of Quality System processes, controls, documentation, and procedures. This includes but is not limited to data integrity, batch release, deviations, CAPA, Document Control, and Change Controls
• Provide oversight of GxP (GLP, GCLP, GMP) processes throughout all phases of the product lifecycle
• Manage qualification and audit (remote or on-site) of vendors involved in preclinical activities and oversee supplier/vendor Quality management, including review of documents such as batch records, validation protocols, test methods, etc.
• Oversee vendor qualification for GCLP activities as needed
• Provide detailed risk assessments throughout product development
• Support quality system processes, including continuous improvements
• Facilitate and support inspections: head on the readiness activities related with the inspection (documentation, mock audit, etc.), lead the inspected team, and coordinate the responses to the inspection findings
• Directly manage quality staff

 

Qualifications and Skills:

• Bachelor’s degree in Life Sciences or related discipline. Advanced degree preferred.
• Typically requires 12+ years of experience, including 5 years of experience working in early-stage biologics QMS
• Experience working in early-stage biologics Quality Management Systems
• Experienced leveraging vendor Quality Management Systems to assure phase appropriate quality compliance of investigational products
• Well versed with relevant industry regulations (FDA, ICH, and other applicable standards)
• Experience with biological drug therapeutics, ideally with some experience working with antibody therapeutics
• Experience working with regulatory authorities
• Experience with conducting vendor/internal audits and leading audit response teams

 

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

 

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. With a Master's degree, typically 8+ years of experience is required. With a Ph.D., typically 5+ years of experience is required

 

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. A