Senior Director, Head Of Quality

Position: Senior Director, Head of Quality

Reports to : Chief Technical Officer

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

Abdera is seeking a Senior Director of Quality Assurance to be the head of quality assurance/compliance to support the company’s clinical programs. This role will be essential to ensure phase-appropriate compliance of product manufacturing and clinical evaluation of our novel oncology therapy candidates. This position provides cross-functional GMP/GCP/GLP compliance support for ongoing and new clinical studies. This position will also be responsible for establishing Abdera’s quality systems and processes to comply with US and EU regulations and guidelines. This position will manage other QA staff and external consultants as needed.

Strong leadership skill and quality technical background is desired. A successful applicant will have prior hands-on 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 be comfortable in a fast moving and nimble culture.

Principal Responsibilities

Building Quality Assurance Team and Capabilities

• Responsible for oversight of the QA function, including Supplier Management, the internal audit program, Quality Systems, Document Control, Training as well as GMP/GCP/GLP compliance.
• Responsible for the design and the implementation of Abdera’s quality management systems to provide oversight and enable contract manufacturing and clinical trials.
• Manage external consultants, as required.
• Oversee hiring, training and development of staff.

Implementing Quality Management Systems

• Drive implementation and maintenance 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 quality initiatives.
• Direct development, initiation, and maintenance of all Quality Systems in support of the product(s) including the Quality Management Review.
• Responsible for internal and external audit preparation, training, and serve as lead FDA/Regulated Authority liaison during audits.
• Select and implement electronic quality system.

Supporting CMC programs and Clinical Trials

• Represent QA on project teams and with contract manufacturers as required. Direct all aspects of quality support and strategy for the project team on the designated product(s).
• Review and approve partner/contractor GLP/GCP/GTP/GMP documentation
• Actively monitor ongoing contractor-related research, manufacturing, quality control testing, and other activities. Provide feedback to stakeholders in a timely manner as per established Quality Agreements.
• Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.

Qualifications, Education & Experience

• Prior experience with IND and early clinical stage oncology programs.
• Competence in FDA and international GMP requirements. Strong working knowledge of GCP beneficial.
• Bachelor’s degree in life science, engineering, or equivalent
• Minimum of ten (10) years of Quality Assurance experience in FDA regulated industry, preferably, biologic or Antibody Drug Conjugate therapeutics.

Qualifications, Education & Experience

• Experience working with contract manufacturers
• Excellent interpersonal and collaboration skills
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Prior experience and knowledge in implementing Quality Management System and electronic document control systems.
• Excellent verbal and written communication skills; ability to lead Quality function as part of multi-faceted projects.

Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

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