Sr. Quality Engineer, Digital System QA
Insmed Incorporated

Job Info

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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

Consistently Ranked Science 's 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've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ 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 GxP business areas such as supply chain, manufacturing, quality control, warehouse, and clinical operations as Quality Assurance representative. This also includes GxP Computer Systems supporting Quality Systems such as Electronic Document Management System (EDMS), Quality Management System (QMS), Learning (Training) Management System (LMS) and Labeling Management Platform. The position requires to have knowledge and understanding of key Quality Systems Process such as Change Control, Deviation, CAPA, Supplier Quality, Internal/External Audit, Quality Complaints and Production Process Control to support GxP computer system utilized in these areas and provide guidance to business users conducting quality system activities as QA.

Responsibilities

Responsibilities will include, but not necessarily be limited to, the following:

• Guide Business Owners and IT System Owners for computer systems validation and lifecycle management deliverables as Digital Systems QA in accordance with applicable regulations, guidelines, policies and procedures.
• Facilitate Computer System Life Cycle Management activities such as IT Change Control, System Releases/Upgrades, Periodic Reviews, Audit Trail Review, User Access Review, Incidents as Digital System QA.
• Train, assist and advise business users on executing GxP computer system validation life cycle management activities within EDMS/QMS.
• Lead GxP IT Change Control cross functional forum assessing GxP Computer System changes to be implemented for continuous improvement.
• Authors SOPs and Quality System records such as Document Change Control, Change Control, Deviation, CAPA, Audit Observations, Risk Assessments, Periodic Review, and assists other departments with the generation, review, approval and maintenance of such records.
• Provide support during regulatory inspections, internal audits and supplier qualifications.
• Experience with Veeva systems is preferred.
• Experience implementing, validating, and controlling 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 Processes (Change Control, Deviation, CAPA, Audits, Supplier Quality, Production Process Control), and quality management tools.

Position Requirements

• Education - BS Degree required.
• 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 approver of 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

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Salary Range

$88,000 - $122,467 a 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, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

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.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

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