Associate Director, Inspection Readiness

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 Director of Clinical Quality Systems, the Associate Director, Inspection Readiness serves as Clinical Inspection Readiness lead for Insmed.

The incumbent will support and collaborate with the Clinical Development functions in establishing Inspection Readiness strategy, tools and guidance, and the promotion of proactive, inspection-ready compliance in the execution of clinical trials.

Responsibilities

Responsibilities : Utilize a risk based quality management approach to facilitate the set-up and implementation of a framework for Inspection Readiness :

• Act as the Business process Owner for Inspection Readiness
• Collaborate with cross functional teams to establish strategy, tools and guidance in support of inspection readiness
• Ensure inspection ready procedures are appropriate to functional responsibilities and clinical trial phases
• Partner with Program leads and the Clinical Compliance Manager to ensure cross-functional buy-in of inspection readiness activities and their effective implementation
• Monitor and track inspection readiness activities and outcomes across programs, ensuring best practices are shared and adopted
• Provide inspection readiness coaching to other staff members
• Work with the Insmed's Regulatory Intelligence team to maintain a current awareness of regulations and regulatory inspection outcomes
• Support regulatory inspections at Insmed, including the assessment and sharing of lessons learned, and their implementation in ongoing inspection readiness processes
• Monitor and track inspection activities, managing the reporting process including facilitation of responses and follow-up corrective and preventive actions

Position Requirements :

• Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 5-10 years of experience.
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
• Experience of participation in regulatory agency inspection and working with regulators and internal staff to help prepare for inspections.
• An understanding of regulations, development processes and regulatory inspection procedures is required.
• An understanding of the sponsor responsibilities in the execution of clinical trials.
• Experience developing SOPs; reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
• Knowledge of GCP and key regional regulations (US, EMEA and Japan).
• Experience of risk based quality management with the ability for critical thinking and a problem solving approach.
• Requires robust experience with quality procedures and processes.
• Must be able to foster a collaborative / partnership environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building while maintaining quality and compliance.
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Demonstrated flexibility, with the ability to work independently, and to manage variable workloads
• Must exhibit Insmed's five (5) core values of : Respect, Passion, Integrity, Collaboration and Accountability.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

LI-JT1#LI-Remote

Salary Range

$139,000 - $195,200 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.