Quality Strategist

Job Description

Job Description

Description:

The Quality Strategist will serve as the primary point of contact for the Quality Assurance Unit (QAU), ensuring all laboratory operations activities maintain ISO, GLP and FDA regulatory standards. This role requires a strategic partner who can navigate complex compliance landscapes while fostering a collaborative relationship with Study Directors (SDs) and technical teams. The ideal candidate is a proactive communicator who prioritizes data integrity and "inspection readiness" as a daily standard. We are looking for a leader who moves beyond the "policing" mindset of QA. You should be approachable, interactive, and solution-oriented , ensuring that quality is seen as a driver of excellence rather than a barrier to progress.

Key Responsibilities including but not exclusive of:

· Regulatory Leadership: Serve as the subject matter expert for 21 CFR Part 11 and GLP regulations. Lead the site through regulatory interactions and external sponsor audits.

· Auditing & Compliance: Oversee a robust auditing program, including facility, process, and study-based inspections. Ensure all findings are resolved through effective Root Cause Analysis and CAPA implementation.

· Process Validation: Lead and perform validations for various laboratory processes, equipment, and test methods. Ensure the eQMS is optimized for vendor and equipment management.

· Documentation & SOPs: Author and refine Standard Operating Procedures (SOPs) to reflect evolving regulatory expectations and operational efficiency.

· Study Director Collaboration: Act as a conversational and interactive partner to the SD team, providing objective challenges to decisions to ensure study integrity without compromising project momentum.

· Archive & Records Management: Oversee the secure management and retention of all raw data and study archives in accordance with retention policies.

· Inspection Readiness: Maintain a "constant state of readiness" for unannounced inspections; develop and report on Quality Metrics via executive dashboards.

· Education: Bachelor’s degree (BS/BA) in a scientific or related field.

· Certification: RQAP-GLP certification is required.

· Experience: 8+ years of progressive experience in Quality Assurance within a regulated (GLP/FDA) environment.

· Leadership: Demonstrated experience in a supervisory or leadership capacity, with a track record of mentoring staff and managing cross-functional relationships

· Communication: Exceptional written and verbal communication skills; ability to translate complex regulatory requirements for non-QA stakeholders

· Problem Solving: Adept at Root Cause Analysis and identifying systemic quality trends.

Preferred skills/nice to have:

· Experience with ISO 17025/9001 compliance and building automated quality dashboards

Physical Requirements / Working Conditions:

· Follow Office Role Requirements from an EHS perspective