Associate Director Quality Assurance - Analytical, GMP - Insmed Incorporated

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

The Associate Director, Quality Assurance - Analytical,GMP has responsibility for the QA oversight of Insmed Gene Therapy (GTx) analytical laboratories, review and approval of GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego, California 

Responsibilities

• QA support of Quality Control:
  • Approve or reject starting materials, packaging materials, labelling and intermediate, bulk and finished products in relation to their specifications (as applicable for internal or external manufacturing/analytical testing)
  • Evaluate completed test records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met
  • Review/approve sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use
  • Approve and monitor analyses carried out under contract through private labs
  • Lead the activities associated with monitoring the maintenance of the department(s), premises, processes, and equipment
  • Review and monitor that the appropriate validations, including those of analytical procedures, and calibration of control equipment are carried out

• Responsible for assisting in any Health Authority inspection preparation, acting as SME when needed and in providing or reviewing responses to findings from such inspections.
• Develop the required working relationships both with the GTx Technical Operations and broader QA teams.
• Assist and oversee deviation, laboratory out of trend and out of specification investigations, Change Control and CAPA/Effectiveness Checks.  Provide expert QA review, collaboration, and direction for laboratory investigations.
• Apply Quality Risk Management for key processes and systems. Identify improvement opportunities and implement changes as necessary.
• Provide support and training to other staff members.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.
• Assist in other quality assurance related activities as agreed with management.

Job Requirements:

• Minimum BS degree in Chemistry, Engineering, Life Science or related discipline required
• A minimum of 10 years of relevant Quality Assurance experience or similar function required  
• Direct experience with Change Control, Document Control, Deviations, CAPAs, and Effectiveness Checks in Gene Therapy 
• Understanding of cGMPs for early phase and late phase gene therapy products 
• Familiarity of pharmaceutical product manufacturing processes and analytical laboratory practices
• Experience working with an electronic document management system (EDMS)
• Experience at reviewing procedural documents, change controls, manufacturing investigations, and lab investigations 
• Demonstrate ability to manage projects and variable workloads
• Must have excellent communication 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)
• Proficient in analyzing data trends in Excel or JMP 
• Experience with LIMS is a plus 

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 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.