Job title: Clinical Quality Assurance Consultant
Job type: Interim / Project consulting
Emp type: Part-time
Industry: Biotechnology
Expertise: Pharmaceutical / CRO / Reagents / Personal Care
Pay interval: Hourly
Location: Raleigh-Durham, North Carolina
Job published: 22 Jul 2020
Job ID: 32051

Job Description



Clinical Quality Consultant




Up To 6 months

Employment Type:



Raleigh-Durham, North Carolina/Remote


Company Background

Our client is a specialist life sciences consulting company that provides product development and regulatory consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies. The company has worked with the worlds leading companies, guiding them through their key product development and regulatory decision milestones, from proof of concept to commercialization and post marketing.


Job Summary

We are looking for a Clinical Quality Consultant to support a gene therapy client as a GCP Subject Matter Expert in guidance over audits and providing GCP QA leadership to their clinical development teams. This is a proactive hands-on position and is responsible for the execution on all strategic GCP activities within the client organization. The Clinical Quality Consultant will work with cross-functional teams to maximize the efficiency of available resources in conducting various clinical compound support QA activities. They will play a key role in supporting the global inspection readiness strategy of our client by proactively leading GCP compliance activities, identifying compliance risks and recommending mitigations.


What Youll Do

  • Serve as the main contact and SME in providing expertise in GCP compliance interpretation for the support of audits (documents, supplier vendors, databases, internal systems, clinical trial sites, etc.) for our gene therapy client.
  • Collaborate with Clinical Operations, Global Clinical Compound Support QA, (CCS QA), CRO vendors, etc. to provide operational quality oversight, whilst assessing compliance with SOPs, GCP/ICH regulations, and clinical study protocols.
  • Liaise with cross-functional teams to develop risk-based audit and compliance strategies for the assigned client compounddrug, whilst enabling teams to be inspection ready.
  • Provide leadership and quality GCP expertise for Clinical Operations Program Study Managers in developing and implementing risk based GCP audits to support clinical programs.
  • Collaborate with Quality and Clinical Operations to determine acceptable vendors and systems for potential engagement and provide continuous ongoing evaluation of overall compliance performance of these vendors.
  • Lead GCP inspection readiness, conduct and follow-up activities for clinical programs.
  • Actively participate in regulatory GCP inspections and ensure inspection expectations and commitments are successfully fulfilled in a timely manner.
  • Oversee audit plan and procedures and engage with appropriate CQA auditors where needed.
  • Lead in the investigation of significant quality and compliance issues (misconducts, breaches, systemic problems etc.), identify root causes, develop corrective actions, determine preventive actions, and escalate as appropriate to internal and external stakeholders whilst presenting potential solutions to senior leadership.
  • Conduct written responses to audit findings and issues from IRBs/EC/regulatory agencies.
  • Perform reviews of Clinical/Data Management processes and clinical study documents (including but not limited to CSRs, DSURs, IBs, TMFs, Clinical Protocols, Site Approval documents, etc.) to ensure compliance with regulations and standards.
  • Actively follow audit and compliance metrics and evaluate the state of GCP compliance whilst identifying risks. Present analyses to leadership and R&D development teams that provide guidance and impact of critical decisions for key stakeholders.
  • Participate in due diligence activities and process improvement initiatives where needed.

Essential Skills/Qualification

  • Bachelor’s degree in a science, medical or related field (advanced degree is preferred)
  • 10 yearsexperience in the biotechnology/pharmaceutical industry with over 7 years of GCP related QA or relevant clinical trial experience.
  • Biologics or cell/gene therapy is highly preferred.
  • Advanced knowledge of global GCP regulations and ICH guidelines.
  • Expertise in proactively preparing for, conducting and reporting audit findings into action plans that identify and mitigate risks.
  • Experience with inspections and hosting regulatory authorities
  • Exceptional written and verbal communication skills, with confidence to present to senior management and leadership.
  • Proficient in conducting conflict prevention and resolution in a respectful manner.
  • Capable of managing complex projects, demanding timelines and acting quickly within a start-up environment
  • Strong judgement and decision-making skills
  • Attention to detail can analyze complex data effectively

Desirable Skills/Qualifications

  • GCP Quality Assurance registration/certification preferred


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