What are the responsibilities and job description for the Director of Quality position at Blue Lake Biotechnology?

Director of Quality

Employment type :

Full-time, exempt, on site

Location

Athens, GA

Blue Lake Biotechnology is a private intranasal vaccine company harnessing the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the lives of vulnerable populations. We aspire to transform the healthcare landscape and create a healthier world with better vaccines for all ages that are painless, easy, and effective. Our PIV5-vectored Covid-19 vaccine and RSV vaccine are in phase 2 clinical trials

We make the most of our team members’ skills and passion by actively supporting our employees to achieve their career goals with us. We also offer a competitive compensation package, benefits and perks.

Job Description

The Director of Quality leads and oversees all aspects of Quality Assurance (QA) to ensure full compliance with Good Practice (GxP) requirements. This role is responsible for managing quality processes related to the manufacturing, clinical evaluation, and clinical sample testing of vaccine products developed. The Director of Quality ensures high standards are maintained across all operations, driving compliance, continuous improvement, and collaboration with cross-functional teams.

Key Responsibilities

What this role will achieve (goals) :

Maintain and ensure compliance with current GxP standards across all operations, focusing on manufacturing, clinical evaluation, and testing of vaccine products.
Develop and improve phase-appropriate quality systems that ensure company-wide adherence to quality objectives and regulatory standards.
Oversee and enhance QA processes, including document control, training, CAPA management, product release, handling out-of-specification results, and quality audits.
Lead internal and external audit programs, ensuring audit findings are addressed and closed in a timely manner.
Serve as the key Quality Assurance representative on the management team, providing strategic guidance on compliance and quality-related issues.

What does success look like (metrics)?

Compliance gaps are identified and addressed with strategies that ensure timely resolution and alignment with GxP standards.

Continuous improvement in GxP processes, with enhanced standard operating procedures (SOPs) and phase-appropriate quality systems in place.

Successful completion of all internal and external audits, with audit findings resolved promptly.

Regular, comprehensive quality metric reports delivered to the company management team, with evidence of sustained or improved compliance.

Seamless collaboration with cross-functional teams to integrate quality considerations across all business units (manufacturing, R&D, clinical operations, etc.).

The Requirements

Soft or Technical Skills needed :

Expertise in GxP regulations and quality systems, with the ability to lead and drive compliance initiatives across diverse operational areas.

Strong leadership and management skills to oversee QA processes and personnel; and cross-functional collaborations, ensuring alignment with company goals.

Excellent communication skills, with the ability to present quality-related matters to management and provide clear guidance to cross-functional teams.

Strategic problem-solving abilities, particularly in addressing compliance gaps, resolving quality issues, and driving continuous improvement initiatives.

Proficient in using and managing electronic Quality Management Systems (eQMS) and other QA software tools.

Work experience needed :

Experience building quality assurance programs and processes in a startup environment with limited resources, specifically within GxP environments in the pharmaceutical, biotech, or vaccine manufacturing industry.

Demonstrated track record of leading internal and external audits, including audits of third-party vendors, and ensuring timely resolution of audit observations.

Experience in developing and implementing quality processes, SOPs, and protocols in compliance with GxP requirements.

Proven success in managing investigational product quality issues, such as temperature excursions, and ensuring product release in clinical manufacturing environments.

Knowledge, education, and / or training needed :

Bachelor’s degree in Life Sciences, Engineering, or related field. Advanced degree preferred.

Extensive knowledge of GxP regulations, quality systems, and compliance requirements for clinical manufacturing and testing.

Continuous professional development in quality management systems, regulatory compliance, and industry best practices.

Additional Information

The company strives to offer a competitive benefit package for our employees including but not limited to the following :

Health, dental, and vision insurance

401(k)

Paid time off

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