Compliance Manager

TetraScience

United States
  • Job Type: Full-Time
  • Function: Legal
  • Post Date: 03/30/2021
  • Website: tetrascience.com
  • Company Address: 294 Washington Street 11th Floor, Boston, MA, 02108

About TetraScience

TetraScience is the leader in transforming the Digital Lab. We provide an advanced data engineering solution that makes life sciences R&D data truly accessible and actionable.

Job Description

Description

TetraScience provides the world’s first and only R&D Data Cloud, with a mission to transform life sciences R&D, accelerate discovery, and improve human life. Scientists at global pharma and biotech organizations rely on our innovative Tetra Data Platform for easy access to centralized, harmonized, and actionable scientific data to accelerate their digital lab transformation. With best-in-class SaaS performance, a team of industry innovators, and excellent product/market fit, Tetra is positioned to become an iconic life sciences software company.

Responsibilities:

  • Maintain familiarity with the TDP and TLM platforms in order to ensure GxP compliance across our products
  • Ensure that TetraScience maintains GXP and SOC-2 compliance
  • Work with TetraScience leadership to ensure that processes across the organization align with necessary compliance measures
  • Prepare TetraScience for audits / risk assessments by conducting semi-annual mock audits; plan for and remediate process deviations
  • Define system QC tests that align with Pharma customers’ expectations
  • Maintain all current compliance and training documentation:
    • Engineering and Security Policies and Procedures (quarterly)
    • Training and logs maintained with CSO and Team Leads (quarterly)
    • SOPs updated, reviewed, and approved (semi-annually)

Requirements

  • Deep experience in life sciences qualification, validation, and compliance activities.
  • Expert knowledge of Pharma lifecycle, processes, and ecosystem
  • Experience with one or more control processes such as SOC-2, 21CFR part 11, or ISO standards
  • BS in physical or life sciences, computer science, political science with 10 years experience, or MS with 5+ years experience
  • Strong attention to detail; sense of accountability, responsibility, and ethics
  • Knowledge of data management technologies
  • Accomplished at writing and auditing policies and procedures
  • Experience working cross-functionally; understanding how to influence and change behaviors
  • Strong project management skills and ability to keep non-dedicated resources on task

Benefits

  • Competitive Salary and equity in a fast growing company
  • Supportive, team oriented culture of continuous improvement.
  • 100% employer paid benefits for all eligible employees and immediately family members.
  • 401K
  • Generous paid time off (PTO)
  • Flexible working arrangements - Remote work + Boston office as needed

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.