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 three 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

Reporting to the Associate Director, Quality Assurance GMP, the QMS Specialist, Quality Assurance, will play a key role in managing QA and Regulatory Compliance activities for Insmed Gene Therapy. This role directly influences Insmed GMP compliance through QA oversight, monitoring and review of Quality System activities. In coordination with the Associate Director, Quality Assurance GMP, primary areas of responsibility include Documentation Review and Approval, Monitoring, Review, and Approval of QMS tasks including Change Controls, CAPAs, Deviations, Effectiveness Checks, Lab Investigations, Training, Periodic Reviews, Quality System Metric Reviews, and related SOPs for these systems. Additional responsibilities include Training, Trending, Monitoring, and Approvals.

Responsibilities

Primary responsibilities include overseeing completion of Quality Management System (QMS) records for Insmed Gene Therapy including Document Change Controls, Change Controls, CAPAs, Deviations, Effectiveness Checks, Lab Investigations, Training, and Periodic Reviews.
Provides input on QMS processes includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations.
Supports facilitation of Change Control Committee materials and review and approval of changes presented to committee.
Facilitates feedback from Change Control Committee Members.
Coaches and guides QMS action owners to ensure effective record initiation, review, approval, implementation, and closure per applicable procedures and regulations. Collaboratively works with cross-functional departments to support QMS activities.
Performs QA review of Change Controls, CAPA, Deviations, and Effectiveness Checks. Ensures completeness, accuracy, and compliance to all applicable cGMP regulations.
Handles compilation of quality metrics for trending and follow up for the closure of process improvements. Presents and communicates trending reports in respective Quality forums.
Supports training of Insmed Gene Therapy employees in QMS processes.
Uploads and routes Quality Records for approval in Veeva Quality Documents electronic documentation system.
Performs QA Document Control review and approval of document updates.
Ensures QMS records comply with process requirements, including use of appropriate document templates, where applicable.
Reviews and updates SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
Tracks ongoing document updates to ensure timely processing.
Monitors documents for Periodic Review process and works with document owners to ensure timely document review and update, as applicable.
Assists in inspection readiness activities and plays a key role during inspections/audits for QMS activities.
Provides support during internal review, Audits, FDA Audits, and Third-party consultant Audits.
Tracks and identifies trends of quality events, including but not limited to Change Controls, Deviations, CAPAs, and Lab Investigations.

Preferred Requirements

Position Requirements (Required and/or Preferred Skills, Experience and Education):

BS degree in Chemistry, Engineering, Life Science or related discipline required.
A minimum of 2 years of relevant Quality Assurance experience required.
Direct experience with Change Control, Document Control, Deviations, CAPAs, and Effectiveness Checks in pharmaceutical or medical device products.
Understanding of cGMPs for pharmaceutical products.
Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
Experience working with an electronic document management system (EDMS).
Experience at reviewing procedural documents, change controls, manufacturing investigations, and lab investigations.
Demonstrate ability to manage projects and variable workloads.
Must have excellent communication skills (verbal and written).
Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Proficient in analyzing data trends in Excel or Minitab.

Salary Range

$73,000 - $97,200 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.

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

Insmed Incorporated jobs

QMS Specialist