Associate Director, QA - GTx Manufacturing
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 and 2022

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 two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work-certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in Biopharma TM List, Small and Medium, and one of the Best Workplaces in New York TM , which recognizes companies headquartered in NY, NJ, and CT.

Overview

The Associate Director has responsibility for the QA oversight of manufacturing build up and operations at Insmed's gene therapy (GTx) manufacturing facility acting in capacity of person in plant representing QA. Also will provide QA support for GTx clinical and pre-commercial product disposition and distribution.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Responsible for review and approval of qualification / validation documents as part of the GTx manufacturing plant and supporting the continued compliant status of the facility.
• Responsible for working in coordination with the GTx site quality groups.
• Responsible for review and approval of master batch records for clinical and / or pre-commercial product, including master batch records for aseptic process simulation studies.
• Focus on establishing, implementing, and maintaining quality operations systems that support manufacturing activities

• 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.

• Perform ongoing review of batch records as part of product release, oversight of deviations and CAPAs, and ensuring good communication of issues, developments and plans. Also, serve as a conduit from the local QA organization to Global QA organization.
• Develop the required working relationships both with the GTx Technical Operations and broader QA teams.
• Assist in laboratory out of trend or out of specification investigations.
• Perform audits, write reports and follow up on audit responses and CAPA implementation.
• Establish QTA's with GTx Technical Operations and CMO's, associated vendors and contracted laboratories.
• Apply Quality Risk Management for key processes and systems. Identify improvement opportunities and implement changes as necessary.
• 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.
• 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.

Position Requirements: In the following categories, indicate specific role requirements and qualifications that are absolutely necessary in order to perform the essential functions of the job.

Qualifications

About You:

• 10 years' experience in Pharmaceutical Industry in a similar function.

• Minimum MS degree in Pharmacy, Chemistry, Life Science or related discipline.
• Full understanding of GMP and Gene Therapy manufacturing.
• Understanding of GDP, FMD, EU inspection procedures, EU Medical device regulation
• Familiarity with Quality Assurance aspects in manufacturing processes of new products.
• Experience with effectively managing regulatory agency inspections, working with regulators, and vendor/supplier audits.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.

• Qualified Person eligibility is a plus
• 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).
Other (if applicable):
• This position will be based in the San Diego, California and requires on-site presence.
• Must successfully exhibit Insmed's five (5) corporate values: Collaboration, Accountability, Passion, Integrity & Respect; along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel Requirements

Up to 15% travel, both domestic and/or international, with periods of 50% and more travel.

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
The base salary range for this job is from $161,667.00 to $188,333.00

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
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

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.

If you need a reasonable accommodation for any part of the employment 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.

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