Director, Clinical Quality Assurance

2 months ago

South San Francisco, United States Abdera Therapeutics Full time
Job DescriptionJob Description

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 relentless in our focus to 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 Director, Clinical Quality Assurance, to lead clinical quality for Abdera’s novel oncology therapy clinical programs.  The Director of Clinical Quality Assurance will be responsible for the development, management, and execution of the GCP QA programs to ensure that all aspects of the drug development process are in accordance with all relevant current FDA and international regulatory guidelines as they pertain to Abdera’s clinical trials.

Salary US  210k - 230K

Responsibilities                                 Provide quality oversight to CROs
  • Provide CQA oversight to Phase I-III global clinical studies to ensure study conduct compliance in accordance with GCP and applicable regulatory requirements.
  • Participates in clinical programs and representing QA as the point of contact interface with Contract Clinical Research Organizations (CROs), and Investigator Sites.
  • Responsible for the QA review of clinical protocols, ICFs, Clinical Investigator's Brochure, Clinical Study Report audits and other clinical trial specific documents.
  • Provide guidance for investigations as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations.
  • Leads the routine and non-routine quality assurance audits that include clinical investigator sites, vendors, process, system, study project and documentation.
  • Ensure inspection readiness preparation with CROs, clinical sites, as applicable.
  • Monitor GCP non-conformance trends across the entire Clinical Development portfolio and communicate this information to management with proposed remediation actions

Build the Clinical Quality capabilities
  • Define quality processes for Clinical Programs.
  • Design and implement the GCP QA strategy and policies.
  • Develop and implement all essential GCP training (including SOPs, external regulations and guidelines) for internal teams and external Contract Service Providers.
  • Identify and drive continues clinical quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations relevant.
  • Serve as the Clinical Quality expert for internal teams and provide guidance on and interpretation of global GCP regulations and standards.

Support Clinical Programs
  • Guide Clinical team in the development of Clinical SOPs and other quality documents.
  • Work closely with GxP Quality Assurance and functional areas responsible for the conduct of clinical research (e.g., Clinical Operations, Clinical Development, Biostatistics and Data Management, Pharmacovigilance, etc.)
  • Recommend and lead the implementation of quality initiatives to ensure clinical compliance to global regulatory requirements (e.g., US FDA, EMA, etc.)
  • Supports regulatory inspections of the company and its clinical vendors as needed.
  • Provides cQA support for safety related monitoring and pharmacovigilance.
  • Identification of investigator sites that may pose a risk to that portfolio, conducting regular investigator site audits and management of subsequent corrective and preventive actions plans (CAPA).
Support building the overall Quality Management Systems
  • Establishes, refines, implements, and maintains cQA systems, policies, and procedures for oversight of the Abdera’s clinical operations.
  • Ensures implementation of a risk-based approach to regulatory compliance.
  • Supports the organization's training program as it relates to GCP and clinical compliance
Qualifications, Education & Experience
  • Minimum of a master’s degree in life science or equivalent and 10+ years' experience in GXP and Quality Systems in biotechnology or pharmaceutical environment.
  • Demonstrated in-depth experience of establishing, refining, and operating Clinical Quality Assurance related systems in the Biotechnology industry.
  • In depth knowledge of regulations and guidance supporting GCP and GLP to include FDA, EMA, ISO standards and ICH guidelines with direct impact to clinical programs.
  • Experience reviewing and collaborating on regulatory submissions as well as hosting inspections/interactions.
  • Experience working effectively with CROs.
  • Experience with electronic Quality Management Systems and Trial Master File.
Skills and Abilities
  • A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
  • Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing.
  • 5-10 years of experience working with the clinics or directly in the clinical settings
  • Demonstrated thought leadership in clinical Quality Assurance.
  • Must be familiar with ICH regulations and FDA/EMA requirements and expectations, plus experience with health authority inspections.
  • Experience in preparing regulatory filings.
  • Strong interpersonal and collaboration skills.
  • Excellent verbal and written communication skills.
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment.
  • Ability to critically evaluate and troubleshoot complex problems and attention to detail.

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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