Associate Director, Pipeline QA at Insmed

Company DescriptionInsmed 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.RecognitionsNamed Science’s Top Employer in 2021, 2022, and 2023Insmed 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 WorkWe 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.OverviewResponsible for directing all quality related activities and process for a pipeline product in clinical phase studies. This includes but not limited to supplier relationships/auditing, batch review/release, site transfers, and internal document set up/review, QMS, weekly team meetings, packaging and labeling. In addition, responsible for facilitating transition from drug development to commercial product.ResponsibilitiesEstablish and maintain a risk-based and scientific-based quality system and decision makingAudit the manufacturing facilities of vendors, customers and outside contract organizations.Approximately 15% Domestic and International travelResponsible for facilitating and approving Quality Technical Agreements with vendorsThrough a quality system approach, ensure phase appropriate GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellenceAbility to apply phase appropriate GMP compliance principles to quality decisionsAbility to lead investigations, CAPAs, deviations and quality events to resolution and closureAbility to transition phase 3 clinical stage material to commercial successManage the quality aspects of a large scope phase 3 clinical project from raw materials to manufacturing to packaging, distribution and releaseProvide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriateBe responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materialsPrepare, 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 to develop additional auditing resources.Act as company’s representative during regulatory agencies and customer inspectionsIdentify and lead operational excellence initiatives, both in the department and company-wide, which result in the overall improvement in both areasPartner with colleagues in other departments to increase the overall effectiveness of the Quality departmentQualifications:Minimum BS degree in Chemistry, Life Science or related discipline plus 10 years. OR Masters, PHD, MBA and 7 years of experience preferredFull understanding of cGMPs, GLPs and a working knowledge of GCPs.Understanding of device regulations and development processes. Understanding of FDA inspection procedures.Familiarity of pharmaceutical product manufacturing processes.Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs.Experience with effectively managing FDA inspections, working with regulators, and customer audits.Experience at writing manufacturing and lab investigations.Batch level – move to auditing programBroad knowledge of risk based quality systems approaches consistent with ICH Q10 for pharmaceuticals.Demonstrate ability to manage staff and projects (direct and indirectly) and variable workloads.#LI-JT1Travel RequirementsUp to 10%Salary Range$139,000 - $195,200 a yearCompensation & BenefitsWe’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 basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS:401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-site, no-cost fitness center at our U.S. headquartersAdditional InformationInsmed 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.Job SummaryExternal ID: R1722Job Function: Quality AssuranceRemote: YesPosition Location (WD) : Location: US-USA-NJ-BridgewaterSalary Range: $139,000 - $195,200 a year