Director, Global Quality Systems – Compliance

Scholar Rock

Director of Quality Systems managing GxP compliance and quality processes for biopharmaceutical industry. Leading initiatives to enhance quality management systems as the organization scales.

Posted 5/11/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesLeadWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Support global Quality Management System (QMS) transition from clinical-stage operations to a commercial-ready, scalable, and inspection-ready environment.
Optimize core QMS processes (change control, deviations, CAPAs, complaints, audits, document control, training, and supplier quality) to ensure they are efficient, phase-appropriate, and scalable for commercial operations.
Establish and drive a proactive compliance framework that ensures sustained inspection readiness and supports global regulatory expectations.
Strengthen the product complaint handling program, ensuring robust intake, triage, investigation, escalation, and trending processes that can support increased product volume and market distribution.
Scale the GxP training program, implementing role-based curricula, improving training effectiveness, and ensuring sustainable compliance as the organization grows.
Lead validation of GxP computerized systems (eQMS, LMS, etc.), ensuring systems are fit-for-purpose, integrated, and capable of supporting commercial operations, with strong data integrity controls.
Build and mature a risk-based supplier quality management program, ensuring suppliers are qualified, monitored, and capable of supporting commercial manufacturing and distribution requirements.
Support the implementation of QMS performance metrics and quality KPIs, enabling data-driven insights, proactive risk identification, and executive-level visibility.
Support internal audit program, focused on identifying systemic gaps and ensuring readiness for commercial inspections.

Requirements

What you’ll need

BS/MS degree in a scientific discipline.
10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years in leadership roles within Quality or related functions.
Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.
Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
Hands-on experience with systems such as Veeva Vault is preferred.
Highly proactive, decisive, and capable of independently managing key initiatives.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Scholar Rock Website LinkedIn All Job Openings 51 - 200 employees Founded 2016 💰 $205M Post-IPO Equity on 2022-06 Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Our most advanced investigational product candidate, apitegromab (SRK-015), a Director, Global Quality Systems – Compliance 🔥 1 hour ago 🏢🏡 Cambridge – Hybrid ⏰ Full Time 🔴 Lead 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Support global Quality Management System (QMS) transition from clinical-stage operations to a commercial-ready, scalable, and inspection-ready environment.
Optimize core QMS processes (change control, deviations, CAPAs, complaints, audits, document control, training, and supplier quality) to ensure they are efficient, phase-appropriate, and scalable for commercial operations.
Establish and drive a proactive compliance framework that ensures sustained inspection readiness and supports global regulatory expectations.
Strengthen the product complaint handling program, ensuring robust intake, triage, investigation, escalation, and trending processes that can support increased product volume and market distribution.
Scale the GxP training program, implementing role-based curricula, improving training effectiveness, and ensuring sustainable compliance as the organization grows.
Lead validation of GxP computerized systems (eQMS, LMS, etc.), ensuring systems are fit-for-purpose, integrated, and capable of supporting commercial operations, with strong data integrity controls.
Build and mature a risk-based supplier quality management program, ensuring suppliers are qualified, monitored, and capable of supporting commercial manufacturing and distribution requirements.
Support the implementation of QMS performance metrics and quality KPIs, enabling data-driven insights, proactive risk identification, and executive-level visibility.
Support internal audit program, focused on identifying systemic gaps and ensuring readiness for commercial inspections. 🎯 Requirements
BS/MS degree in a scientific discipline.
10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years in leadership roles within Quality or related functions.
Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.
Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
Hands-on experience with systems such as Veeva Vault is preferred.
Highly proactive, decisive, and capable of independently managing key initiatives. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Director, US Regulatory Affairs – Advertising and Promotion 🕒 6 days ago Sanofi 10,000+ employees 💊 Pharmaceuticals 🧬 Biotechnology ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Director of US Regulatory Affairs ensuring compliance with advertising and promotion regulations and collaborating across teams. Leading strategic decision-making and implementing regulatory strategies for marketed products. 🏢🏡 Cambridge – Hybrid 💵 $178.5k - $257.8k / year 💰 Post-IPO Equity on 2022-03 ⏰ Full Time 🔴 Lead 🚔 Compliance 🦅 H1B Visa Sponsor Director of Quality, Compliance and Audit 🕒 March 20 Philips 10,000+ employees ⚕️ Healthcare Insurance 🧬 Biotechnology Website LinkedIn All Job Openings Director of Quality leading global compliance engineering and internal audit for Philips Health Technology. Focused on regulatory compliance, team leadership, and quality system improvements. 🏢🏡 Cambridge – Hybrid 💵 $181k - $287k / year ⏰ Full Time 🔴 Lead 🚔 Compliance 🦅 H1B Visa Sponsor View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System (QMS)change controldeviationsCAPAsauditsdocument controlGxPquality KPIsrisk-based supplier quality managementdigital quality systems

Soft Skills

proactivedecisiveindependent managementleadershipcommunication