Position Descriptions & Qualifications

Your expertise in compliance could find you a home in the Hub.

Consulting | Senior Consultant

Example Experience:  Minimum of fifteen (15) years of experience as a Quality and/or Compliance professional working in the FDA, regulated industry (i.e. Medical Device, Pharmaceutical, Biotechnology, etc.) or as a Consultant. Masters or Doctorate level of education, or equivalent experience preferred. Must be proficient in writing and presentations skills. The ability to travel both domestic and internationally is a major aspect of the role.

Example Responsibilities:  Lead Auditor, Subject Matter Expert, Coach and Trainer in a FDA regulated environment. Work solo or on teams providing strategic consultation and/or performing remediation following FDA Compliance Actions (FDA-483s and Warning Letters). Team Lead and/or Project Manager/Leader on large or complex projects with multiple work streams (includes the management of resources). Must have the ability to audit and assess Device Quality System and/or Drug GMPs to ensure compliance with FDA Requirements.

Technical Experience: Experience in conducting, managing, and leading internal/external audits, which may include QSR and/or cGMP audits. Experience in the area of FDA Inspection Preparation, subject matter expert for FDA inspections, and developing responses to FDA-483 observations.

Experience as Subject Matter Expert (SME) in more than one of the following areas: Complaint Handling and Post Market Reporting, Production & Process Controls (including Process Validation), Design Controls, Risk Management, CAPA, Computer System Validation, Purchasing & Supplier Controls, Management Controls, etc.

In-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806, as well as ISO 13485, 14971 and related International Requirements.

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Consulting | Associate Consultant

Example Experience:  Minimum of six (6) years of experience as a Quality and/or Compliance professional working in the FDA or in regulated industry (i.e. Medical Device, Pharmaceutical, Biotechnology, etc.), or as a Consultant..Bachelors or Masters level of education, or equivalent experience preferred. Must be proficient with writing and presentations skills. The ability to travel both domestic and internationally is a major aspect of the role.

Example Responsibilities:  Team Auditor, Consultant, or Technical Advisor working in a FDA regulated environment. Work solo or on teams performing remediation or providing tactical consultation in response to FDA Actions (FDA-483s and Warning Letters). Experience working on large or complex projects with multiple work streams. Experience in reviewing Device Quality System and/or Drug GMP documentation to ensure compliance with FDA and ISO Requirements Sub-team lead of one or more project teams is desired.

Technical Experience: Experience in at least one of the following areas: Complaint Handling and Post Market Reporting, Production & Process Controls (including Process Validation), Design Controls, Risk Management, CAPA, Computer System Validation,, Purchasing & Supplier Controls, Management Controls, Recalls and Training.
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Consulting | Project Manager

Example Experience:  Bachelors in a Life Science, Business or Project Management discipline or related field. Master’s preferred. At least five years of project management experience within the medical device or pharmaceutical industries in coordinating and organizing team projects. At least three to five years consulting project teams.

Example Responsibilities: Point person responsible for daily hands-on management of assignments throughout the lifecycle of an assigned project including the project team. Develop project planning, tracking and process monitoring activities, including development of the necessary tools and documents. Create and maintain schedules, workflow, documents as well as communication within the consulting team. Plan, track and align deliverables to the scope of the project. Perform quality assurance oversight for outcomes and personnel involved in the project. Report on output and outcomes. Proven experience with project management computer tools and software to map out project plans, update status and communicate with project team. Experience in document control. The ability and willingness to travel.
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Corporate Office | Consulting Director

Example Experience: 20+ yrs. Master’s degree or equivalent experience. Significant Medical Device or BioPharmaceutical Industry experience.

Example Responsibilities:  Oversight Level of Quality of Consulting Product. An SME in multiple disciplines and/or extended Compliance or Regulatory experience including 12-15+ years in auditing or 5+ years within the FDA. Typically managed large national and/or international teams. Strategic Consultation – Interacts with health authorities.
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