Sr Quality Engineer Quality Systems
Insmed Incorporated

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science's Top Employer in 2021, 2022, and 2023

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 Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

Overview

This position is primarily responsible for supporting and providing oversight to Validation and Life Cycle Management activities for GxP Computer Systems used to support the end-end GxP Supply chain including the Quality Management System, manufacturing, quality control, warehouse, and clinical operations. The position will provide end users guidance on Computer Systems utilized to support quality management system activities such as Electronic Document Management System, and additional GxP systems for Gene Therapy manufacturing, quality control, warehouse, and clinical operations. The position will serve primarily as the QA for Computer Software Validation lifecycle management documents and Quality Systems documents/records such as Policies, Procedures, IT Change Control, Deviations, CAPA, Supplier Qualification, Periodic Reviews etc. This is a non-supervisory position.

Responsibilities

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

• Represent Digital Systems QA as a GxP computer system validation expert and provide oversight and guidance on computer systems validation in accordance with applicable regulations, guidelines, policies and procedures.
• Support Computer System Life Cycle Management activities such as System Changes, Upgrades, Periodic Reviews, Audit Trail Review, Incidents as Digital System QA.
• Train, support and advise end users on GxP Computer System validation practices and EDMS/QMS system requirements and workflows.
• Lead GxP IT Change Control cross functional subject matter expert forum assessing GxP Computer System changes to be implemented for continuous improvement.
• Writes SOPs and other quality system documentation, assists other departments with the generation, review, approval and maintenance of such documents.
• Provide support during regulatory inspections, internal audits and supplier qualifications.
• Experience with Veeva systems is preferred.
• Experience implementing, validating, and maintaining, GxP Computer Systems in validated state in an FDA or equivalent regulated settings.
• Role-related knowledge: Working knowledge of all GxP regulations and guidances including 21 CFR Part 11, Annex 11, ICH Harmonized Guideline Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation, Quality Management Systems, and quality management tools.

Qualifications

• Education - BS Degree preferred.
• A minimum of 5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered.
• Experience in working in a GxP regulated industry and preferably in quality assurance role.
• Experience as QA reviewer of several GxP records and processes: Change Controls, Computer System Validation Deliverables, Deviations, CAPA, SOPs, etc..
• Must be familiar with 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity and SDLC (Agile or Waterfall) .
• Quality Professional Certificates such as ASQ Certified Software Quality Engineer, ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, preferred.
• 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 10% travel

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $88,000.00 to $122,467.00 per year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

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.

Applications are accepted until the position is filled.

This job has expired.