Title: Manager, QA Clinical Operations

　　Type: Direct Hire

　　Location: Cumberland, Rhode Island (Relocation assistance available)

　　Salary: Competitive !

　　Start: January

　　Overview:

　　Join our dynamic team as a Manager of Quality Assurance Clinical Operations you will lead the nonclinical/clinical QA function to develop and implement a quality system in accordance with ICH Guideline E6 (R2) Good Clinical Practice (GCPs), 21 CFR part 58 Good Laboratory Practices (GLP), and other global regulatory authority requirements, and industry practices. This Quality Assurance role assists in maintaining various projects including COMPANY’s Design Control program for existing and new products and quality oversight of ongoing and future clinical trials.

　　Responsibilities:

　　Serve as resource for interpretation and evaluation of GCP and Pharmacovigilance compliance issues for Clinical Development, Quality Assurance, and Regulatory Affairs.

　　Support the QA and Compliance, Clinical Operations, and Product Development teams to develop and maintain audit programs and phase appropriate compliance standards.

　　Ensure COMPANY clinical and development programs are conducted in accordance with regulatory guidance.

　　Coordinate, schedule, plan, and periodically conduct internal and external audit Conduct Quality assessments / audits of Suppliers, Principal Investigators and COMPANY GLP & GCP activities, follow-up on agreed upon corrective actions and deliverables from cross-functional teams.

　　Review audit reports and propose improvement strategies; follow up on responses and CAPAs and ensure their implementation in a timely manner.

　　Conduct vendor assessments and/or qualification visits for outsourced Clinical Operations, Biometric, Regulatory affairs, Clinical Labs, and Pharmacovigilance activities.

　　Support the review and analysis of clinical operations quality and compliance through monitoring of Key Quality Indicators and assured gaps addressed to proactively mitigate risk.

　　Establish risk-based program for continual monitoring of performance, maintenance, and appropriate oversight of all GCP and GLP suppliers.

　　Develop, monitor, and report on GxP Compliance, including:

　　The company’s Readiness and GxP Inspection Execution Competent Authority

　　The handling of all clinical complaints, non-conformances, corrective actions, clinical temperature excursions and return material authorizations (RMA)

　　Support and maintain training curricula for departments/staff across different line functions within Clinical and Product Development.

　　Requirements:

　　Bachelor's degree in Applied Sciences or other applicable experience

　　6+ years Clinical QA compliance/auditing experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines and or equivalent relevant experience.

　　At least 5 years of GCP/GLP site auditing experience

　　Ability to manage a small team in clinical quality and support.

　　Advanced knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GxP governing the conduct of pharmaceutical development activities

　　Excellent knowledge of US cGLPs.

　　Knowledge or experience of auditing to GCP requirements

　　Significant to advanced experience using Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint) required.

　　#M3

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.