About the Role:
Reporting to the Senior Director, CMC Quality Assurance, the Associate Director, CMC Quality Assurance is responsible for directing all quality related activities and process for 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 for drug substance, drug product, packaging and labeling. In addition, you will be responsible for facilitating transition from drug development to commercial product.

What You'll Do:

In this role, you'll have the opportunity to establish and maintain a risk-based and scientific-based quality system and decision-making approach. You will also:

• Audit the manufacturing facilities of vendors, customers and outside contract organizations.
• Facilitate and approve 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.
• Apply phase appropriate GMP compliance principles to quality decisions.
• Lead investigations, CAPAs, deviations and quality events to resolution and closure.
• Transition phase 3 clinical stage material to commercial success.
• Manage all quality aspects of phase 1 through phase 3 clinical projects 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.
• 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 companywide.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.

Who You Are:

You have a minimum of a BS degree in Chemistry, Life Science or related discipline. MS, PhD, MBA and more than 7 years of equivalent QA experience in regulated industry such as pharmaceutical, biologics or device. In lieu of advanced degree 10 or more years equivalent experience will be considered.

You are or you have:

• Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads.
• Full understanding of cGMPs, GLPs and a working knowledge of GCPs.
• Understanding of device regulations and development processes.
• Familiarity of pharmaceutical product manufacturing processes, small molecule and biologics.
• 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.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.

Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

Travel Requirements

This position involves frequent domestic and international travel up to 25%.

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Pay Range:
$155,000.00-201,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.