Senior Quality Engineer, Quality Assurance

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 Reporting to the Associate Director of Quality Management Systems, the Sr. Quality Engineer 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. Primary areas of responsibility include, Monitoring, Review and Approval of Change Controls, facilitating Change Control Committee meetings, Monthly/Annual Quality System Metrics/Reports, and related SOPs for these systems. Additional responsibilities include training, trending, monitoring, QA review and approval of Quality Documents in the electronic Document Control System, and business continuity across other processes within the QMS team. Responsibilities Primary responsibilities include overseeing processes within the QMS related to Change Control and electronic Document Control. This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified QMS processes. Maintains all activities to support Change Control processes. Supports facilitation of Change Control Committee materials and prior review of Change Plans presented to the committee. Facilitates feedback from Change Control Committee Members. Coaches and guides process owners to ensure effective change control initiation, approvals, implementation and closure per applicable procedures and regulations. Collaboratively works with cross-functional departments to support change control activities. Performs QA review of Change Controls. Ensures completeness and accuracy of content and compliance to all applicable SOPs and cGMP regulations. Handles compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Responsible for presentation and communication of trending reports in respective Quality forums. Performs Quality review of documents to support Document Control processes. Training of QA and stakeholders in QMS processes. Develops supplemental training materials. 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. Tracking and identifying trends of quality events, including but not limited to change controls. Role will be cross trained on all QMS process for business continuity (Document Control, Deviation, CAPA, EC, etc) and will act as QA approver/reviewer as required. Qualifications: · BS degree in Chemistry, Life Science or related discipline required, plus a minimum of 5 years of relevant Quality Assurance experience required. OR an advanced degree (MS) and a minimum of 3 years relevant experience will also be considered. · Direct experience with Change Control, Document Control, and Deviations/CAPAs, 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 Quality Management System (QMS) and document management system (EDMS). · Experience at reviewing procedural documents, change controls, manufacturing investigations, and lab investigations. · 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. LI-JT1 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 TotalRewardsinsmed.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.