Quality Engineer CAPA and Systems

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 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 Management Systems (QMS), the Quality Engineer CAPA and Systems, will play a key role in managing QA and Regulatory Compliance activities for Insmed.

This role directly influences Insmed GMP compliance through QA oversight, monitoring and review of Quality System activities.

In coordination with the Associate Director, QMS, primary areas of responsibility include QA review and approval of Deviations / CAPAs / ECs, QA review and approval of Quality Documents in the Document Control System, tracking and trending.

Responsibilities for this role include business continuity across other processes, including Change Control and reporting Monthly / Quarterly Quality System Metrics.

Responsibilities also include management of related SOPs for these systems, training, and continuous quality improvements.

Responsibilities

• Responsibilities (Essential Role Responsibilities) :
• Primary responsibilities include oversight of processes within the QMS related to Deviations, CAPAs, Effectiveness Checks, and electronic Document Control System.

This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified Quality processes.

• This role will work collaboratively with both internal QA team members and cross-functional departments to support QA activities.
• Performs QA review of Deviation / CAPA / EC. Ensures completeness, accuracy, and compliance to all applicable cGMP regulations.

Coaches and guides stakeholders to ensure effective initiation, approvals, implementation and closure of QMS records per applicable procedures and regulations.

• Reviews and evaluates corrective / preventive actions (CAPA) including the CAPA effectiveness program. Responsible for communicating CAPA status to cross-functional departments and external partners.
• Supports and / or leads the investigation of complex deviations. Ensures thorough investigations are conducted using various root cause analysis techniques and that all investigations are technically sound / properly documented, with corrective actions for prevention of reoccurrence identified.
• Maintains activities to support Document Change Control process, including oversight of controlled document lifecycles, document change requests, classification, and on time periodic review.
• Reviews all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods and specifications, and technical documents, as applicable, ensuring all documents are maintained to latest revisions and format.
• Supports compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements.

Presentation and communication of trending reports in respective Quality forums.

• Tracks and trends quality events and records related to Quality Documents and QMS.
• Performs training for QA and stakeholders in QMS processes.
• 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.
• Identifies and implements process improvement projects to drive success in the areas of Quality Management Systems.
• Assists in inspection readiness activities and plays a key role during inspections / audits.
• Provides support during internal review, Audits, FDA Audits and Third-party consultant Audits.
• Role will be cross trained on all QMS processes (Document Control, Deviation / CAPA / EC, and Change Control) and will act as QA approver / reviewer as required.
• Assigned duties / projects, as needed, to support continuous quality improvements.

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

• BS degree in Chemistry, Life Science or related discipline required.
• A minimum of 3-5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered.
• Direct experience with Deviations / CAPAs, Document Control, and Change Control, in pharmaceutical or medical device products.
• Full 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, manufacturing investigations, lab investigations, and change controls.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and / or ISO 14971
• 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.
• Preferred ASQ CQE certification.

Travel Requirements

Up to 10%

LI-JT1

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.