About the role

Aplyr's Quick Take

This role is about leading the quality engineering and computerized systems assurance efforts at Serán BioScience. You'll be responsible for ensuring compliance with regulatory standards and maintaining validation processes across manufacturing and laboratory operations. It's a senior-level position that involves strategic oversight rather than hands-on technical work.

Good fit

Ideal candidates have extensive experience in quality assurance within the biotech or pharmaceutical industries, particularly with GMP regulations. A collaborative leadership style and a strong understanding of validation processes are essential.

Worth noting

This position involves significant interaction with regulatory bodies and could be high-pressure during audits. The location in Bend, Oregon, may appeal to those looking for a balance between professional and outdoor lifestyles.

Serán BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization’s validation, qualification, and computerized systems assurance programs. This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.

This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.

The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.

Skills & Tags

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Aplyr's read

Serán BioScience is a dynamic biotechnology firm innovating in diagnostics and therapeutics, attracting a diverse workforce from scientists to business developers.
Synthesized from recent postings & public sources

What's promising

•Strong focus on developing cutting-edge diagnostics and therapeutics.
•Recent hiring across diverse roles indicates growth and expansion.
•Opportunities for career advancement in a specialized biotech field.

What to watch

•Biotechnology sector can be volatile and subject to regulatory changes.
•Limited public information about financial stability and long-term viability.
•Highly specialized roles may limit opportunities for generalists.

Why Serán BioScience

•Specializes in both diagnostics and therapeutics, offering a broad scope of innovation.
•Recent expansion into commercial manufacturing suggests strategic growth.
•Emphasis on quality assurance highlights commitment to regulatory compliance.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Serán BioScience

Serán BioScience

seranbio.com

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Serán BioScience is a biotechnology company focused on developing innovative solutions for healthcare, particularly in the areas of diagnostics and therapeutics.