Head of Quality Assurance

Abdera Therapeutics • South San Francisco, CA

54d • Hybrid

About The Position

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! 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.

Requirements

• Bachelor’s degree in chemistry, biochemistry, pharmacy, pharmacology, or related scientific discipline required.
• At least 18 years of Quality Assurance experience in FDA regulated industry
• Prior experience with FDA submissions including IND and early-stage experience required.
• Competence in FDA, international GMP and GCP requirements.
• Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organizations.
• Experience in leading Quality function in fast paced early clinical stage companies.
• Builds a learning environment that recognizes the value of each contributor and promotes a solutions-oriented mindset.
• Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes to create the most efficient and effective methods to deliver quality clinical trial services.
• Willingness to collaborate with team to identify and implement best practices for optimizing performance.
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• Strong leadership skills in leading team members and vendors.
• Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight.
• Strong organizational, communication and interpersonal skills
• Ability to prioritize, delegate and execute quality responsibilities and deliverables to meet project deadlines.

Nice To Haves

• Master’s Degree, PharmD or PhD preferred.
• Prior expertise in Radiopharmaceutical desired.

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 and direction for clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs).
• Provide QA leadership on project teams and contract manufacturers. Direct all aspects of quality support and strategy for the project team on the designated product(s).
• Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.
• Actively monitor ongoing contractor-related manufacturing, quality control testing, and other activities. Provide feedback to stakeholders in a timely manner as per established Quality Agreements.
• Review and approve partner/contractor GLP/GCP/GMP quality agreements and documentation

Benefits

• Health, Dental, Vision, Prescription drug coverage, Basic Life and AD&D insurance, both Long-Term and Short-Term disability 16 paid company holiday, 20 days of PTO and 6 sick days to ensure your well-being, as well as a 401k plan with up to 3.5% company match, equity and bonus to help secure your financial future.
• We also offer a hybrid work schedule with 3 days on-site along with development and growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level