Clinical Quality Assurance

Position Description

 

Job Title: Clinical Quality Assurance

 

Classification: Full-Time, Exempt, Salaried

 

Shattuck Labs, Inc.

Shattuck Labs, Inc. (“Shattuck”) has developed the first-in-class Agonist Redirected Checkpoint (ARC) platform technology for immunotherapy, which harnesses the human immune system to improve survival for patients battling cancer and inflammatory disease. Shattuck’s proprietary technology represents the next evolutionary step in cancer therapy by endowing one molecule with multiple functions with applicability across the entire spectrum of human disease. Specifically, Shattuck has developed novel fusion proteins for cancer immunotherapy and other disease areas. Shattuck, based in Austin, Texas, is a privately-held biotechnology company founded in 2016. The Research and Development hub for Shattuck is based in Research Triangle Park, NC.

Job Description

We are seeking a Clinical Quality Assurance position to be responsible for the ongoing development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Shattuck Labs. The primary responsibilities will be to ensure both the quality and compliance of Shattuck Labs sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, EU, ICH, and country specific), along with current industry standards and practices. Specifically, the Clinical Quality Assurance candidate will:

·        Draft, review or revise Clinical SOPs to assess consistency and compliance with regulatory requirements/internal standards

·        Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management

·        Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary

·        Conduct and/or assist in vendor audits (systems, processes, vendors, computer system validation)

 

·        Work directly with CRO’s and other external contractors and collaborators, managing the chain of communication related to GCP compliance

 

·        Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs)

·        Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process

·        Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents

·        Assist and advise with training Quality and Clinical staff as necessary for GCP

·        Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation

·        As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management

·        Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management

·        Assist with inspection readiness and regulatory inspections as needed

Qualifications

·        At least 5 years of direct GCP pharmaceutical/biotechnology experience

·        Solid understanding and application of GCP, GLP and ICH requirements, especially ICH E6R2

·        Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing

·        A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments

·        Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments

·        The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events

·        A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations and business needs

·        Experience with using risk-based principles and decision making to ensure compliance at all stages of development

·        Proven track-record of leadership and building relationships with both internal and external vendors

·        Strong negotiation skills, flexibility and ability to provide a solution-based approach to emerging challenges


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