Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.
In partnership with Contract Research Organization, the Clinical Quality Assurance Director will support the establishment, implementation and management of the quality assurance strategy across multiple studies. The CQA Director will assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
This role is accountable for GCP and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations).
Primary Responsibilities include but not limited to:
- Provide GCP compliance advice and guidance to project teams, to achieve continuous quality improvement and effective quality management.
- Interface with relevant stakeholders, including regulatory, clinical operation and clinical development to provide GCP expertise.
- Prepare and conduct QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders, and interact with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
- Proactively identify, analyze and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.
- Lead the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements).
- Participate in the development/enhancement of QA procedures, guidance documents and audit tools.
- Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents,
- Act as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of GCP, PV regulations and guidelines as well as local regulations.
- BS/BA degree in a relevant area with 8+ years (Director) or 6+ (Associate Director) of experience in the pharmaceutical industry in a QA role.
- Extensive vendor and site audit experience.
- Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization.
To be considered for this opportunity, please submit your resume/CV referencing the position code to email@example.com. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.