Quality Assurance Director - QC Oversight

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 Exec. Director Quality, the QA Director, QC will play a key role in supporting QC activities for Insmed. He/she will be responsible for Quality related activities for Global development and commercial products. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers.

Responsibilities

• Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues.
• Responsible for supplier day to day relationships of critical laboratories. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistency.
• Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & procedures
• Lead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc
• Provide oversight of QC equipment program, which includes qualification, calibration, PM, etc
• Review and approve deviations, CAPAs, SOPs and Change Control related to QC Lab operations
• Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements.  This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).
• Manage the performance and development of 0-5 direct reports.
• Support supplier and internal audits as necessary.
• Act as company's representative during regulatory agencies and customer inspections.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
• Support Statistical Trending of Manufacturing and Analytical Data.
• Other responsibility as assigned by manager

Position Requirements:

• BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 10 years of relevant Quality Assurance experience; advanced degree and a minimum of 8 years relevant experience required
• Experience in sterile drug product, tablets, biologics, gene therapy preferred
• Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.
• Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines.
• Solid knowledge of all QC laboratory equipment
• Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
• Experience with internal and external audits.
• Experience reviewing QC validation documents.
• Demonstrate ability to manage projects and variable workloads.
• Excellent communication and coaching skills (verbal and written). 
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. 
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

#LI-JT1

Travel Requirements

Some travel may be required - 10%

Salary Range

$171,000 - $239,667 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.