Director, Product Release

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Oversee the Quality Program for Grifols Plasma Operations relating to the plasma warehouse and plasma testing laboratories and the product release activities relating to the release of all plasma for the further manufacturing of medicinal products.

• The release of plasma for the further manufacturing of medicinal products in accordance with all US and European regulations
• Review and ensure the compliance with all Quality Agreements established between Grifols Plasma Operations and manufacturing customers
• Review and ensure the compliance with all Quality Agreements established between Grifols Plasma Operations and plasma suppliers.
• Oversee the quality operations of the Grifols plasma warehouses.
• Develop, author, review, and approve standard operating procedures used by the Grifols plasma warehouses.
• 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, process and procedures as it relates to the plasma warehouses and testing laboratories 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 warehouse and testing facilities
• Oversee internal and external audits of quality systems within plasma warehouse and testing laboratories. Act as liaison with external domestic and international auditors.

Education & Experience

• A Bachelor's Degree in a medical or biological science.
• A minimum of two 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.

Knowledge & Skills

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.

Occupational Demands

• 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 task, 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.

EEO Minorities/Females/Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

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Location: [[mfield6]] : [[cust\_building]]

Learn more about Grifols

Req ID: 355507

Type: Regular Full-Time

Job Category: Manufacturing