compliance lead

Overview

Remote
Depends on Experience
Contract - Independent
Contract - W2

Skills

Good Clinical Practice
Agile
LIMS
IQ
Leadership
Life Sciences
Management
Master Control
Data Integrity
Documentation
GAMP
GLP
GMP
Google Cloud Platform
Auditing
Reporting
Risk Assessment
SAP
Software Development Methodology
OQ
PQ
Pharmaceutics
QMS
Quality Assurance
RTM
Change Control
Collaboration
Communication
Computerized System Validation
GxP
Training
URS
Veeva
Waterfall
Regulatory Compliance
System Implementation
Test Management
Test Plans
Trackwise

Job Details

Key Responsibilities
Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities.

Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness.

Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11).

Provide compliance oversight during system implementation, upgrades, or configuration changes involving systems such as LIMS, QMS, eTMF, qTest, Vera, or SAP.

Collaborate with IT, QA, and business teams to review and approve system validation deliverables: URS, FS, RTM, test plans, IQ/OQ/PQ.

Lead internal audits and regulatory inspections, and act as the primary point of contact for audit planning, execution, and response.

Monitor and interpret updates from regulatory authorities (e.g., FDA, EMA, MHRA) and translate requirements into actionable compliance initiatives.

Manage deviations, investigations, and CAPAs related to both operational and computerized system compliance.

Generate and report compliance metrics, trends, and risk assessments to quality leadership.

Required Qualifications
Bachelor s or Master s degree in Life Sciences, Pharmacy, Regulatory Affairs, Computer Science, or related field.

Minimum 7 10 years of compliance or quality experience in the pharmaceutical, biotech, or life sciences industry.

Proven expertise in GxP compliance, CSV (Computer System Validation), and SDLC governance.

Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP5, and data integrity principles.

Demonstrated experience working with validated systems and structured documentation practices.

Excellent communication skills with the ability to lead cross-functional initiatives.

Preferred Qualifications
Certifications such as RAPS, ASQ, or GAMP.

Familiarity with test management and compliance tools (e.g., qTest, Vera, Veeva Vault, TrackWise, MasterControl).

Experience supporting clinical and commercial operations from a systems compliance perspective.

Knowledge of Agile and Waterfall SDLC models in regulated environments.

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