Director, Pathogen Safety

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:

Director of Pathogen Safety is a senior leadership role responsible for defining and executing pathogen (viral) safety strategies for new and existing biotherapeutic products. The position leads global projects across R&D and CMC, ensuring scientific excellence, regulatory compliance, and alignment with state‑of‑the‑art technologies while meeting company objectives and timelines.

Primary responsibilities:

• Lead and manage pathogen safety strategies and studies for product development and lifecycle management.
• Act as Study Director or site responsible for internal and external pathogen safety studies in GLP and non‑GLP environments.
• Oversee project planning, execution, budget control, and cross‑functional coordination within multidisciplinary teams.
• Evaluate and interpret pathogen safety study results, reporting progress to project teams and R&D management.
• Prepare, review, and approve technical reports, risk assessments, and regulatory documentation supporting registration dossiers.
• Ensure full compliance with GMP, GLP/BPL, quality, safety, and environmental standards, and promote a strong safety culture.

Knowledge, Skills, & Abilities:

• Experience in project management, especially in the areas of plasma  or biotechnology products
• Proven ability to take strong leadership role in organizational issues
• Experience in managing strategic and operational aspects of relationships with internal and external partners.
• Ability to make appropriate judgments on safety policy and compliance
• Team player with excellent communication skills. Able to effectively communicate sensitive issues both inside and outside the organization.

Requirements:

• Advanced scientific degree, Ph.D. or M.D.
• 10+ years experience in Pharmaceuticals and biotechnology with experience in one or more of the following areas: quality assurance, biological processing, virology, biochemistry, and biotechnology development.  Background in virology, TSE and viral clearance study design desired.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.  Frequently walks. Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels 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. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

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.

Location: NORTH AMERICA : USA : NC-RTP:USNC0003 - RTP NC-Research Building 85 

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