Assoc Director, Quality Management Systems

Company Description

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Recognitions

Named Science’s 2021 Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s 2021 Top Employers Survey.

A Certified Great Place to Work

We believe we have built something truly special at Insmed, and our employees agree. Each day, we show up for each other and for the patients we serve. That’s why we were recently certified as a Great Place to Work in the U.S.

Overview

This position is primarily responsible for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system), and Veeva QMS (electronic Quality Management System), LIMs (laboratory Information Management), etc. for the San Diego site. The position will also serve as the QA reviewer for Computer Software Validation, GMP training liaison, and record archiving.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

Responsibilities (Essential Role Responsibilities):• Manage, maintain, and continuously improve Insmed’s global Electronic Document Management System (EDMS), Quality Management System (QMS), additional Quality owned software platforms (labeling, metrics, etc.) and electronic GxP record archiving.• Serve as QA electronic system validation expert and will provide oversight and guidance on computer systems validation in accordance with applicable regulations, guidelines, policies and procedures.• Train, support and advise end users on EDMS and QMS system requirements and workflows. Develop training modules for EDMS and QMS.• Lead EDMS and QMS cross functional subject matter expert forum for continuous improvement.• Manage the GMP document lifecycle management process, which includes, providing guidance, formatting, content, management, archival, and retrieval of documents.• Manage periodic reviews of procedural documents and Document Change Control Programs.• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.• Act as site training liaison with Corporate Compliance to ensure system GMP training set up for San Diego site.• Ensure adequate document archiving (mostly electronic, some physical).• Provide support during regulatory inspections and internal audits.• Experience with Veeva systems is preferred.• Experience implementing, validating, maintaining and integrating electronic document and Quality Management in an FDA or equivalent regulated settings.• Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation and quality management tools.

Qualifications

• Education – BS Degree required or preferred• Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..• Must have excellent communication skills (verbal and written).• Demonstrate ability to manage projects and variable workloads.• Highly organized with a strong attention to details, clarity, accuracy, and conciseness.• Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies

Travel Requirements

Up to 30% travel, both domestic and/or international, with periods of 50% and more travel.

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep all submissions on file for six months.

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