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
Responsible for directing all quality related activities and process for a pipeline product in clinical phase studies. This includes but not limited to supplier relationships/auditing, batch review/release, site transfers, and internal document set up/review, QMS, weekly team meetings, packaging and labeling. In addition, responsible for facilitating transition from drug development to commercial product.
Responsibilities
Experience in leading investigations, CAPAs, deviations and quality events to resolution and closure
Establish and maintain a risk-based and scientific-based quality system and decision making
Audit the manufacturing facilities of vendors, customers and outside contract organizations.
Approximately 15% Domestic and International travel
Responsible for facilitating and approving Quality Technical Agreements with vendors
Through a quality system approach, ensure phase appropriate GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence
Ability to apply phase appropriate GMP compliance principles to quality decisions
Ability to lead investigations, CAPAs, deviations and quality events to resolution and closure
Ability to transition phase 3 clinical stage material to commercial success
Manage the quality aspects of a large scope phase 3 clinical project from raw materials to manufacturing to packaging, distribution and release
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate
Be responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials
Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, customers or to support the quality assurance function. Provide support and training to other staff members to develop additional auditing resources.
Act as company's representative during regulatory agencies and customer inspections
Identify and lead operational excellence initiatives, both in the department and company-wide, which result in the overall improvement in both areas
Partner with colleagues in other departments to increase the overall effectiveness of the Quality department
Qualifications:
Minimum BS degree in Chemistry, Life Science or related discipline plus 10 years. OR Masters, PHD, MBA and 7 years of experience preferred
Full understanding of cGMPs, GLPs and a working knowledge of GCPs.
Experience in effectively managing FDA inspections, working with regulators, and customer audits .
Understanding of device regulations and development processes. Understanding of FDA inspection procedures.
Familiarity of pharmaceutical product manufacturing processes.
Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs.
Experience with effectively managing FDA inspections, working with regulators, and customer audits.
Experience at writing manufacturing and lab investigations.
Batch level - move to auditing program
Broad knowledge of risk based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
Demonstrate ability to manage staff and projects (direct and indirectly) and variable workloads.
#LI-JT1
Travel Requirements
Up to 10%
Salary Range
139000-195200
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 affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.
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.
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.
