Manager, Quality Compliance

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

Manager, Quality Compliance will play a key role in setting strategy and managing QA Global Regulatory GMP Compliance activities for Insmed in both the US and across global sites. This individual will be responsible for Insmed GMP Inspection Readiness, key compliance issues, and Internal Audits. This position will partner to ensure overall effectiveness of the Quality Organization within Insmed. The scope of this role includes commercial and development GMP activities.

Responsibilities

Responsibilities:

• Partner with QA Leadership to ensure GMP inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.). For US activities, act as the primary health authority inspection back room lead.
• Create, maintain/update and monitor the internal audit process for GMP related activities including the annual schedule, reports and CAPA monitoring.
• Perform internal audits
• Create and maintain Standard Operating Procedures relating to areas of responsibility including Internal Audits, Health Authority Inspections, Field Alerts, Quality Manual and Quality Policy, etc.
• Responsible for the monthly metrics and management review
• Partner with business stakeholders and QA Leadership to ensure overall effectiveness of the Global Quality Organization.
• Lead Insmed Quality Intelligence team for regulation changes
• Support key investigations
• Lead process improvement projects
• Other duties as assigned

Qualifications:

• BS degree in Chemistry, Engineering, Life Science or related discipline required.
• A minimum of 10 years of relevant Quality experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.
• Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
• Auditing experience required
• Direct Global Quality experience preferred.
• Must have had Health Authority inspection experience.
• Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, in pharmaceutical and/or medical device products.
• Experience with internal and external audits.
• ASQ CQE and CQA Certification preferred.
• Must be able to partner and collaborate well cross functionally, at all levels.
• Must have excellent communication and influence skills (verbal and written).
• Should demonstrate the ability to manage projects and variable workloads.
• Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.

Domestic and/or International travel required (upto15 %)#LI-JT1

Travel Requirements

up to 15%

Salary Range

$111,000 - $156,133 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 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: 10/1/2024