Corbus Pharmaceuticals

Director, Clinical Quality Assurance – GCP

Corbus Pharmaceuticals

full-time

Posted on:

Location Type: Hybrid

Location: Norwood • Massachusetts • United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • The Director, Clinical Quality Assurance, reporting directly to the Senior Director, Head of Quality, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities
  • Manage the GCP Quality interface and support for all Clinical Project Teams
  • Identify and access compliance risk and develop and implement risk mitigation measures
  • Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents
  • Review and approve Clinical SOPs
  • Develop and Implement Clinical QA SOPs
  • Develop and implement detailed audit plans and yearly GCP audit schedules
  • Ensure the timely and effective follow up of all identified or assigned quality issues
  • Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested
  • Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans
  • Direct and/or deliver yearly GCP training for internal staff as needed
  • Work closely with Clinical Development, Clinical Operations, and other clinical functions/departments to ensure compliance readiness
  • Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies
  • Provide management reports on audit strategy, plans, and findings
  • Support process improvement initiatives; lead continuous improvements within Quality
  • Maintain knowledge of GCP regulations, guidelines, company standards and procedures
  • Preferred experience in providing oversight and supporting GLP related studies

Requirements

  • 12+ years relevant work experience within the GxP (GCP heavy) Biotechnology/Pharmaceutical industry
  • Scientific or engineering degree (BSc, MSc, PhD), Min Bachelor of Science Degree in Biology, Biomedical Engineering, Engineering, or equivalent
  • Knowledge of Good Clinical Practice (GCP) FDA, MHRA and EMA regulatory requirements applicable to Biologics therapy products
  • Very good scientific and medical/clinical expertise
  • Solid expertise in GCP and ICH clinical requirements, clinical development and methodologies of clinical studies
  • Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
  • Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels
  • Well organized and detail-oriented; must be able to effectively prioritize work
  • Eager to learn, interact cooperatively and effectively with others in a team environment
  • Possess advanced word processing, data entry and data presentation computer skills
  • Ability to influence and work effectively with business partners across regions and cultures
  • Displays organizational leadership qualities and effective coaching abilities
  • Listening, interpreting, and summarizing information skills must be highly developed
  • Ability to work both independently with direction and within project teams to attain goals
  • Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs)
  • Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
  • Strong organizational skills and the ability to participate effectively cross-functionally
  • Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment
  • Fluency in written and spoken English
  • Fluency in Chinese is a plus
  • Demonstrated ability to lead on-site corporate, external, or Health Authority inspections
  • A self-starter and a team player who thrives in a fast-paced dynamic team environment
  • Proficiency in using Veeva Clinical and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
  • Veeva Quality is a plus
  • Certification as an auditor by an organization recognized is desirable within the pharmaceutical industry
Benefits
  • Willingness to travel to various meetings/audits
  • May require approximately 10-25% travel
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Good Clinical Practice (GCP)Standard Operating Procedures (SOPs)audit managementrisk mitigationclinical development methodologiesclinical trial documentationregulatory complianceproject managementdata presentationscientific expertise
Soft Skills
effective communicationorganizational leadershipteam collaborationdetail-orientedinterpersonal skillscoaching abilitiesflexibilityindependent workprioritizationconsensus building
Certifications
auditor certification