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Job Details

Skills

SaaS
HIPAA
ISO 9000
System On A Chip
Release Management
Quality Management
Mergers and Acquisitions
Regulatory Compliance
Hosting
Auditing
Pharmaceutics
GxP
Management
Leadership
Communication
Insurance
SAP BASIS

Summary

A commercial SaaS company that works in the biotech and medtech space is looking for a Staff level Compliance Manager to come in and ensure their software products are in FDA, HIPPA, ISO, SOC, etc compliance. You'll ensure that their validation processes are aligned with their software products, handled product release management oversight, and be responsible for the organization's compliance frameworks.

Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have developed Quality Management Systems, authored GxP Validation Packages, and have had leadership roles.

This role is 3 days hybrid in Cambridge, MA.

Required Skills & Experience

12+ years of experience in software compliance or validation
Experience acting as an independent senior compliance individual contributor inside a software product company
Experience leading and hosting customer audits for top 20 pharma or biotech companies
Direct experience with FDA 21 CFR Part 11, CSA, and GxP frameworks
Management and leadership experience
Strong communication skills

The Offer
You will receive the following benefits:

Medical, Dental, and Vision Insurance
Vacation Time
Much more

Applicants must be currently authorized to work in the US on a full-time basis now and in the future.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10105282
Position Id: 883285
Posted 5 days ago

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Staff Compliance Manager / GxP

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Staff Compliance Manager / GxP

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