Associate Director, Inspection Manager
Remote, MA 02139 US
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Title: Associate Director, Inspection Manager
Hiring Organization: Connexion Systems & Engineering
- Duration: TEMP to PERM
- Pay rate: $ 70-$100 /hr
- Job Location: Boston or Remote
- Job# 14929
Reporting to the Director of Inspection Management within Research & Development Quality (RDQ), Associate Director will aid in the establishment of planning and supporting regulatory inspections, ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.) and will be responsible for conducting Regulatory Authority pre-inspection, during inspection and post-inspection activities supporting GLP, GCP, GVP across R&D. The appointee will partner with R&D to create a quality culture.
Here’s What You’ll Do:
- Partner closely with members of R&D to support the successful and compliant execution of regulatory inspection activities.
- Develop and maintain Inspection Management plans and strategies for the R&D Quality inspection management program.
- Review and provide input into study team inspection readiness activities, storyboards, etc.
- Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
- Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained.
- Actively participate as a key member of the inspection team for inspections of R&D programs.
- Provide expert guidance and direction in the development of responses to Regulatory Authority inspection findings for inspections of R&D programs.
- Participate in regulatory authority inspections, including planning, logistics, training and execution, and provide input and review of responses to inspection observations and regulatory agency questions resulting from these inspections.
Here’s What You’ll Bring to the Table:
- BS/BA, MS or PhD and a minimum of 15-20, 10-15, 10 years’ experience,
- respectively, in Biotech, Pharma or Clinical Research Organization.
- Expert knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines, and local legislation.
- Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
- Experience working with CROs, vendors, and relationship management.
- Strong interpersonal skills and ability to interact effectively with all levels within the organization.
- Proven record training, mentoring, and managing a staff of quality professionals.
- Experience coordinating, training and logistical planning for regulatory authority inspections and developing responses to regulatory authority inspection findings.
- Ability to solve complex problems taking a broad perspective to identify innovative solutions.
- Ability to manage multiple projects in a fast-paced environment.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
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Regional Recruiting Manager
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