Biotechnologist Advisor/CQA Senior Manager

Clearance Level
None
Category
Biotechnology
Location
Remote, Based in West Virginia

REQ#: RQ125194

Travel Required: 10-25%
Public Trust: None
Requisition Type: Regular

We are GDIT. We support and secure some of the most complex government, defense, and intelligence projects across the country. At GDIT, Biotechnologist/CQA Senior manager makes an impact in the review and auditing process of external clinical vendors.

GDIT is your place. You make it your own by bringing your ideas and unique perspective to our culture. By owning your opportunity at GDIT, you are helping us ensure today is safe and tomorrow is smarter.

Responsibilities:

  • Attend internal meetings by project. Provide quality leadership to DVC team
  • Represent CQA and participate in multiple project team meetings (w/Subcontractor) and provide counsel, as appropriate through Clinical Manager, on regulatory/compliance issues.
    • With DVC Clinical, perform subcontractor pre-award assessments and qualifications
    • Under supervision of Dir of Quality Systems (DQS)and Clinical Manager plan, conduct or lead qualification, due diligence, and/or for-cause audits, as needed
  • Develop risk-based audit plans focusing on subject care and well-being and adherence to protocols and GCPs for clinical investigator site audits
  • Lead under supervision of DQS and Clinical Manager review, audit planning, execution of audits includes MOPs, ICFs, TMF and authoring of audit reports for quality assurance audits of external clinical vendors and/or clinical investigator sites which includes, but is not limited to: Investigational Sites, GxP service providers, CROs, Central Laboratories, etc.
  • Author comprehensive audit reports emphasizing audit findings related to quality and compliance issues and/or industry best practices and ensure CAPA plans are developed to address quality and compliance issues identified during audits
  • Submit external audit reports, assessments and CAPA plans to DQS and Clinical Manager for review vs. audit plan and to confirm CAPAs address audit findings to meet DVC expectation.
  • Collaborate with clinical team in follow-up to CRO and/or clinical site audits to ensure audit findings are resolved. Follow-up/track CAPA plans through completion and provide metrics.
  • Develop for internal review and then implement clinical quality management plans (CQMPs)
  • Review key essential documents and data such as study-specific procedures, clinical trial protocols/amendments, TLFs, eCRFs, TMFs, informed consent documents, study plans, clinical study reports, etc., to ensure compliance to applicable regulatory requirements (e.g., ICH E6 and FDA regulations) and all executed clinical trial records for GCP compliance.  Interface with appropriate departmental subject matter experts (SMEs) during the review of technical documents for the assessment of compliance to subcontractor procedures and regulatory/contract requirements; escalation of events or risks as needed
  • Review of clinical trial protocols and final reports; determination of adherence to protocols and regulatory requirements; escalation of events/risks, as found
  • Provide quality review of Clinical documents to be submitted to Regulatory Agency if needed
  • Assist in proactive identification of potential clinical compliance risks and mitigation strategies
  • Assist with Regulatory Agency Inspections and responses, if needed.

Requirements:

  • Bachelor’s degree (BA or BS); degree in a science field preferred.
  • 10 years’ experience in the biopharmaceutical industry
  • 3 years in a Quality role (knowledge of Good Clinical Practices (GCPs), GDPs, and 21 CFR Part 11 Compliance
  • Computer literacy in MS Office product suite, Adobe, electronic document management system (EDMS), clinical trial management systems (CTMS), electronic data capture systems (eDC) involving both on-premises and hosted environments for capture of CRF data
  • Strong leadership and management skills, including excellent planning, timeline development and contingency planning
  • Strong interpersonal skills for interacting in team environment with DVC client team
  • Travel required (5-10%, mostly domestic)

About Our Work

We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.

COVID-19 Vaccination

GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.