Director, Product Release

• Ensure the release of plasma for the further manufacturing of medicinal products is in accordance with all US and European regulations.
• Review and ensure compliance with all Quality Agreements established between Grifols Worldwide and manufacturing customers.
• Oversee activities and provide leadership to the team responsible for management of supplier quality to ensure suppliers meet the standards set forth by procedures and regulations.
• Lead a team that manages supply and supplier qualifications, deviations, defective soft goods, investigations, quality agreements and general interactions with 3rd party suppliers and vendors.
• Review and ensure compliance with all Quality Agreements established between Grifols Worldwide and plasma suppliers.
• Responsible for managing the Grifols Plasma Quality Database (PQD) used to manage the plasma donor centers, plasma testing laboratories, plasma storage locations, and plasma refrigerated carriers.
• Oversee the quality operations of the US Grifols Plasma Logistic Centers.
• Develop, author, review, and approve standard operating procedures used by the US Grifols Plasma Logistic Centers.
• Assess skills, knowledge, and abilities of candidates to make effective hiring decisions and identify developmental needs of staff members, including training, disciplinary action and performance management processes.
• Regularly examine quality systems, processes and procedures as it relates to the US Plasma Logistic Centers for increased efficiency and/or increased quality assurance as necessary.
• Act as liaison with quality/regulatory counterparts in international and domestic corporate positions, ensuring programs, systems, software are symbiotic in nature and in compliance with product release requirements for the US Plasma Logistic Centers.
• Oversee internal and external audits of quality systems within US Plasma Logistic Centers. Act as liaison with external domestic and international auditors.
• Acts as Subject Matter Expert in projects involving US Plasma Logistics Centers and product release.

• Knowledge of quality systems preferably in a biopharmaceutical setting or in a regulated industry.
• Must have good oral and written communication skills with experience writing and establishing procedures for quality systems.
• Must have good working skills with MS Office suite.
• Ability to examine existing processes and procedures for efficiency and increased quality assurance.

• A Bachelor's Degree in a medical or biological science, Master’s degree is preferred.
• A minimum of 10 years’ practical post-graduate experience in collecting and/or testing, preparing, storage and distribution of human blood and blood components. Experience managing employees strongly preferred with demonstrated experience in analyzing data to make individual and/or large-scale decisions. Experience with initiating and implementing change.

• The employee is frequently required to stand, walk, sit, use hands and arms, talk and hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance, color, peripheral vision, depth perception, and the ability to adjust focus. Extended periods of sitting, using keyboard, mouse and viewing computer monitor screen. The noise level in the work environment is usually moderate.
• Employee must have the ability to apply common sense understanding to carry out detailed written and oral instructions.
• Employee must perform a variety of tasks, influence others, and use judgement to plan and accomplish goals.
• Employee may be exposed to toxic and caustic chemicals and frequently to biological hazards in the donor center.
• Employee may be required to travel 35% of the time. Travel will include driving and both domestic and international flights.

Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]

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