Sage Therapeutics Jobs

General Scope and Summary

SAGE Therapeutics is searching for a highly motivated, detail-oriented individual with excellent communication skills (both written and verbal) to join our QA IT Team as a QA IT Specialist Consultant. This role will support QA oversight of Data Integrity and Computer System Validation activities for GxP Computerized Systems.

Roles and Responsibilities (Essential Functions)

• Supports and monitors the Data Integrity Program including managing the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, interim controls, remediations, etc.).

• Conducts data integrity assessments to ensure compliance with regulatory requirements.

• Supports the development and review of data process maps.

• Participates in audit trail risk assessments and audit trail reviews.

• Supports the implementation and maintenance of data integrity controls.

• Delivers training on data integrity to foster awareness and accountability.

• Provides support for QA Oversight of Computer Systems Validation (CSV) activities related to initial implementation, changes, maintenance and decommissioning of GxP systems.

• Supports the review of quality event records (e.g., IT Change Control, Deviation, CAPAs, etc.) for GxP systems.

• Reviews and approves CSV deliverables ensuring adherence to regulatory requirements and Sage policies and procedures.

• Actively participates in the release impact assessment process and approval of SaaS releases.

• Supports the periodic review process of validated GxP computerized systems. Reviews, analyzes and identifies compliance gaps incurred throughout the lifecycle of GxP systems.

• Supports the development and revision of QA IT and CSV procedures and validation templates.

• Collaborates across functions and within Quality to identify areas of improvement.

• Evaluates project timelines to correctly ascertain proper time/resource estimates.

Experience, Education and Specialized Knowledge and Skills

Suitable candidates must thrive and excel in an environment that embraces “putting people first,” teamwork, change, risk-based decision making, and flexibility. Successful candidates must be self-motivated to take action, possess strong attention to detail, be open to sharing ideas, and be comfortable with healthy/productive conflict and conflict resolution.

Basic Qualifications

• A minimum of five (5) years of demonstrative, practical experience in Quality Assurance overseeing CSV of GxP computerized systems.

• Strong understanding and hands-on experience in implementing and maintaining data integrity principles and controls.

• Strong understanding of 21 CFR Part 11, EU Annex 11 regulations and GAMP 5 concepts, applications, and best practices.

• Strong working knowledge of computer system validation, computer software assurance, GAMP-based risk assessment and risk management approach.

• Possesses strong written and verbal communication skills.

Preferred Qualifications

• Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation, and maintenance.

• Strong team player that has a customer service approach and is solution oriented.

• Attention to detail and the ability to work individually, within a multi-disciplinary team.

• Understanding of configuration management, software development and CSV lifecycle, Agile/Scrum and Waterfall development approaches.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

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