Director/Sr. Director, Quality Systems and GxP Compliance
- Serve as the Quality Lead for Quality Systems and Compliance operations across the company and manage quality and compliance guidance to the quality function.
- Oversee and manage GxP Training, Document control, and QMS GxP operations—including change controls, deviations, CAPAs, complaints, audit records, and supplier management activities.
- Track and manage the lifecycle of quality system records to uphold the integrity and compliance of Scholar Rock’s Quality system.
- Ensure timely intake and triage of product complaints, accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments.
- Assign and manage GxP training via training system, monitor compliance, and generate training completion reports, as needed.
- Participate in validation efforts for new or updated GxP IT systems through review of documentation, execution of test scripts, and supporting change controls as needed.
- Compile and provide metrics related to Quality management system and suppliers for periodic Quality management review meetings.
- Implement and oversee Scholar Rock’s internal audit program.
- Facilitate continuous improvement initiatives to transform and maintain compliance, improving QMS business process efficiency.
- Support inspection readiness activities, as needed.
- Support regulatory submissions including but not limited to annual reports, IND/CTA updates, and/or marketing authorizations.
- Lead and manage the Quality Systems and Compliance team, including direct reports.
- Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).
- BS/MS degree in a scientific discipline
- 10+ years of experience in the pharmaceutical/biotech industry, with 5–7 years in leadership roles within Quality or Quality related functions.
- Deep understanding and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities.
- Experience leading and managing regulatory inspections and interfacing with Global Health Authorities.
- Demonstrated understanding of electronic Quality Management Systems, Document Management Systems, and Learning Management Systems.
- Hands-on experience with systems such as Veeva Vault is preferred.
- Highly proactive, decisive, and capable of independently managing key initiatives.
Recommended Jobs
Estimator
We are seeking a detail-oriented and experienced Estimator to join a leading mechanical contractor. The ideal candidate will have a strong background in mechanical systems estimating, including HVAC,…
Physical therapist assistant
Position: Physical Therapist Assistant (PTA) Setting: Outpatient Orthopedic Clinic Schedule: Part-Time (Wednesdays & Fridays), with potential for future Full-Time opportunity Overview: …
Principal Product Manager, Crash & Claims
Cambridge Mobile Telematics (CMT) is the world’s largest telematics service provider. Its mission is to make the world’s roads and drivers safer. The company’s AI-driven platform, DriveWell Fusion®…
Professional Dental Hygienist
Job Description Job Description General dental practice located in Pepperell, MA, is looking to add a registered dental hygienist to our team. We are a team of close knit professionals and our pa…
Real Estate Accounting Manager - up to $160k
Real Estate Accounting Manager - up to $160k We’re hiring a Real Estate Accounting Manager to lead financial reporting and property accounting for a growing portfolio of commercial real estate a…
Associate Team Leader
Our Company At H&R Block, we believe in the power of people helping people. Our defining Purpose is to provide help and inspire confidence in our clients, associates, and communities everywhere. W…
Anesthesiologist - Per Diem
Equal Opportunity Employer/Disabled/Veterans According to the FTC, there has been a rise in employment offer scams. Our current job openings are listed on our website and applications are received…