Head of Quality Assurance

Who we are
Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.
Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy!
What we look for
At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are devoted to advancing novel treatment options that offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face.

We are building an exciting and fast paced company passionate about discovering and developing tomorrow’s most innovative cancer therapies.
Abdera is seeking a Head of Quality Assurance to build and lead the company’s quality capabilities. This senior leadership role is responsible for developing, implementing, and executing the company's overall quality strategy, ensuring compliance with GxP regulations across all stages of product development and manufacturing. Key responsibilities include building and leading the quality team and culture, managing the Quality Management System, overseeing quality control and assurance, managing audits, providing cross-functional GMP/GCP/GLP compliance partnership for ongoing and new clinical studies, and acting as the primary quality contact for regulatory agencies and external partners
Strong leadership skills and quality technical background are required. A successful applicant must have prior hands-on early phase quality experience taking a novel cancer therapy through IND and into clinical trials, setting up and maintaining quality management systems, overseeing external GMP contract manufacturing and CRO, and be comfortable in a fast moving and nimble culture.

Salary range:

TBD
Principal Responsibilities
Building Quality Assurance Team and Capabilities

• Develop and implement a comprehensive quality strategy aligned with business objectives.
• Lead the QA function, including Supplier Management, Audits, Quality Systems, Document Control, Training, as well as GMP/GCP/GLP compliance.
• Build, mentor, and lead a high-performing quality team, fostering a culture of accountability and continuous improvement.
• Provide quality oversight to enable contract manufacturing and clinical trials.
• Develop and manage quality budget
• Implementing Quality Management Systems
• Oversee the development, implementation, and maintenance of the Quality Management Systems including Quality Management Review
• Implement and integrate risk management strategies throughout the product lifecycle.
• Identify and mitigate risks associated with quality and compliance associated with product lifecycle.
• Drive continuous improvement of document control systems and promote adherence to company policies, SOPs, and guidelines.
• Identify and anticipate trends in quality issues, collaborate with leadership team to implement continuous improvement and quality initiatives
• Analyze Key Performance Indicators (KPI’s) and report status of quality systems to Executive Committee
• Responsible for internal and external audit preparation, training, and serve as lead FDA/Regulated Authority liaison during audits
• Supporting CMC programs and Clinical Trials
• Support clinical trial operations by ensuring all aspects of ICH GCP are followed
• Provide clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations
• Provides strategic leadership…