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Clinical Quality Assurance Manager

Direct Biologics


Job Details

Full-time

3/15/2024


Full Job Description

Direct Biologics is a market leading innovator and science-based cGMP manufacturer of regenerative biologic products. We are currently looking for a Clinical Quality Assurance Manager.

General CQA Responsibilities:

  • Create risk-based Quality Audit Plans for each clinical trial study / program and ensure they are implemented and executed.
    • Perform Vendor, Investigator Site, PV, and document audits.  Manage the risk management for planning GCP audits.
  • Perform final site regulatory approval and release of IMP.
  • Occasional quality control review of packaging and shipping activities which includes approving records.
  • Supports VP of Quality with tasks related to product quality including but not limited to IMP temperature excursions, document reviews/approvals, and risk assessments.
  • Assist Regulatory Affairs by providing content for Safety reports, Annual Reports, INDs, BLA’s, and amendments.
  • Provide CQA oversight and auditing of eTMFs.

CQA QMS Responsibilities:

  • Coordinates and authors the development, review, comment management and approval of GCP related policies and procedures.
  • Assures that procedural documents have the appropriate SME review and do not conflict with other procedures or overall GCP requirements.
  • Maintain Clinical Development Glossary as it relates to Policies and SOPs.
  • Coordinate Training on SOPs/Policies/Work Instructions (WIs) as related to Clinical Development.
  • Assist the VP of Quality with establishing annual training for Clinical Development.
  • Facilitates and assists in the development of Clinical Corrective and Preventative Plans.
  • Assist the VP of Quality with the management and coordination of  sponsor inspections, and other regulatory agency sponsor inspections of offices in relation to GCP activities.
  • Perform Internal Audits for other departments.

Requirements

  • Strong understanding of clinical development and study processes as they relate cross-functionally.
  • Experience writing SOPs (ideal if you have written Work Instructions, Forms/Templates).
  • Experience in metrics design, risk assessments and evaluations to provide program/study level quality oversight.
  • Excellent communication skills and ability to work with people in all levels of the organization and externally.
  • Excellent project management and organizational skills.
  • Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
  • Ability to deal with cross-functional teams from Clinical Development.
  • Understanding of quality risk management and quality by design principles.
  • Demonstrates skills in problem solving, works independently and in a team environment.
  • Ability to multi-task and manage conflicting/changing priorities
  • 3–6 years pharma experience (minimum of 4 years in a GCP environment working in a Clinical Compliance group)
  • 3+ years’ experience conducting GCP audits (including internal PV audits, Site QA audits and vendor audits)
  • Bachelor’s Degree in a life-science
  • Must be willing to travel up to 25% for onsite audits and company meetings
  • Demonstrates competency in the design/development of SOPs, supporting documents and performance support tools
  • Experience using Electronic Document Management Systems is preferred

Benefits

  • Health Care Plan (Medical, Dental & Vision)
  • Company 401k match up to 4%
  • Paid Time Off (Vacation & Sick)
  • Holidays
  • Stock Option

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