Associate Director, Quality Systems Job at Insmed Incorporated
Company Description:
Named Science’s Top Employer in 2021 and 2022
A Certified Great Place to Work
Overview:
Responsibilities:
Qualifications:
ADDITIONAL U.S. BENEFITS:
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.
Please note that we review every submission, and we will keep all submissions on file for six months.
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:
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.
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™ List, Small and Medium, and one of the Best Workplaces in New York™️️, which recognizes companies headquartered in NY, NJ, and CT.
This position is primarily responsible for providing strategic oversight to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated regulatory and security requirements. Position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system), Veeva QMS (electronic Quality Management System), and additional GxP systems for Gene Therapy manufacturing, quality control, warehouse, and clinical programs. The position will serve as the QA lead for Computer Software Validation lifecycle documents, site IT Change Control facilitation and QA review of CSV documents.
Responsibilities:
- Manage, maintain, and continuously improve Insmed’s global Electronic Document Management System (EDMS), Quality Management System (QMS), additional Quality owned software platforms (labeling, metrics, etc.) and electronic GxP record archiving.
- Serve as QA electronic system validation expert.Provide oversight and QA support on all GxP software used by the Gene Therapy business in accordance with applicable regulations, guidelines, policies and procedures. Types of systems may include: CTMS, LIMS, CMMS, ICN, ERP (inventory management), laboratory equipment software, building management, environmental monitoring, etc.
- Train, support and advise end users on EDMS and QMS system requirements and workflows. Develop training modules for EDMS and QMS.
- Liaising with corporate QA, eead EDMS and QMS cross functional subject matter expert forum for continuous improvement.
- Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.
- Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.
- Provide support during regulatory inspections and internal audits.
- Experience with Veeva systems is preferred.
- Experience implementing, validating, maintaining, and integrating electronic document and Quality Management in an FDA or equivalent regulated settings.
- Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.
- Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities
- Partner with colleagues in other departments to increase the overall effectiveness of the Quality department
- Additional duties as may be assigned from time to time
Qualifications:
- Education – BS Degree required or preferred
- A minimum of 5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered
- Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..
- Preferred experience in Data Integrity, 21 CFR Part 11, GAMP, CDLC (Agile or Waterfall)
- Must have excellent communication skills (verbal and written).
- Demonstrate ability to manage projects and variable workloads.
- Highly organized with a strong attention to details, clarity, accuracy, and conciseness.
- Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies
Up to 10% 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 $135,000.00 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.
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.
Please note that we review every submission, and we will keep all submissions on file for six months.
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