ISO Certified Lab Manager

ISO Certified Lab Manager

A dynamic, rapidly expanding contract manufacturer in the health and wellness sector is seeking a results-driven ISO Certified Lab Manager to oversee their microbiology and chemistry lab. This organization specializes in cutting-edge custom formulations and premium nutraceutical products. As the primary leader for lab operations, this individual will play a critical role in improving productivity, quality, and regulatory compliance as the lab scales.

This leadership position will champion quality initiatives and steer all aspects of laboratory performance to support production timelines and client deliverables. As the quality and compliance backbone, this person will take charge of ISO/IEC 17025 audits, validations, proficiency testing, and ensure the lab remains compliant with industry regulations including cGMP, 21 CFR 111, and other relevant standards.

This Role Offers:

Opportunities for professional growth and cross-training in a dynamic and regulated industry

Exposure to a wide range of product formulations and testing methods in the booming nutraceutical space

Local travel only (50% between nearby lab sites), with occasional out-of-state travel for training

Fast-paced environment with mission-critical impact on product quality and business continuity

Focus:

Lead daily operations for a team of 15+ microbiologists and chemists, the majority of whom are new and require robust onboarding and performance coaching.

Manage compliance with ISO 17025, cGMP standards, and FDA regulatory frameworks applicable to nutraceutical manufacturing.

Oversee all audit preparation and lead third-party inspections, including an imminent ISO 17025 audit.

Develop and improve SOPs, validate new methodologies, and implement proficiency testing.

Execute long-term planning for automation and digitization through LIMS implementation (in progress).

Ensure rigorous adherence to safety standards, documentation protocols, and test validation procedures.

Monitor team output and optimize lab throughput for high-volume production cycles.

Conduct quality assurance functions such as internal audits, test result approval, COA generation, and vendor management.

Support interdepartmental collaboration across QA, R&D, and operations to align testing performance with broader business priorities.

Skill Set:

Bachelor’s degree in Microbiology, Biochemistry, Biology, Chemistry, or related scientific discipline required.

7+ years of progressive laboratory experience, with at least 5 years in a leadership or management capacity.

Strong background in microbiology, with experience in phage, probiotics, enzymes, or botanical ingredients strongly preferred.

Prior experience in nutraceuticals, dietary supplements, or high-compliance consumer health manufacturing ideal.

Proficient in ISO 17025 systems and requirements, including test validation, audit preparation, and staff training.

Hands-on familiarity with LIMS or similar digital lab management platforms is a major plus.

Strong organizational leadership and change management skills, particularly in building high-functioning teams.

Working knowledge of 21 CFR Part 111 and familiarity with quality systems and documentation controls.

About Blue Signal:

Blue Signal is an award-winning, executive search firm specializing in various specialties. Our recruiters have a proven track record of placing top-tier talent across industry verticals, with deep expertise in numerous professional services. Learn more at bit.ly/46Gs4yS