Associate Director, Pipeline QA & Investigations

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

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.

Location: Bridgewater, NJ, US

Posted Date: 11/27/2024