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Supplier Quality Associate

3 months ago

Bridgewater, United States Insmed Incorporated Full time

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 Director, Supplier Quality, the Supplier Quality Associate will support key Supplier Quality Programs: External Supplier Deviations, Supplier GxP Certificate Management, Supplier Notification, Supplier Qualification Activities, External Supplier Audits, and the execution of Quality Technical Agreements. • This individual will be responsible for assisting in the day-to-day management of the supplier quality processes. • This individual will also partner with internal cross-functional stakeholders as required to meet key supplier quality metrics. • The scope of this role includes commercial and development (clinical) GMP. • Participate in key CI projects as needed and perform other duties as assigned.

Responsibilities

Facilitate the management of the External Supplier Deviation Program. Partner with internal stakeholders to drive resolution and on time completion of external supplier deviations. Maintain trending data and escalate as required.Facilitate the management of the Quality Technical Agreement (QTA) program by partnering with internal stakeholders and providing administrative support to ensure QTA's are current, effective, and their on-time completion of the periodic reviews.Assist and collaborate with cross functional SME's and business owners in the selection, qualification, and onboarding of new suppliers.Monitor the execution of the supplier notification program to ensure notifications are raised, evaluated, and assessed within the stipulated time frame within the program or SOP.Assist in the management of Supplier Audits Program to ensure audit plan is met, audit reports are closed on time and follow through on observation for their effective on-time closure.Perform supplier audits as assigned.Manage assignments, ensure timely completion of scorecards.Generate action items from supplier KPI's for system enhancements and improvements, i.e. external deviation trending, supplier notifications, audit reports, and observations to implement value-added system enhancements.Adhere to the supplier's policies and procedures, as well as global regulations and expectations (e.g., FDA, ISO, etc.).Assure supplier quality-related documentation and records are completed thoroughly and timely to maintain compliance.Support the monitoring of the supplier audit program to ensure adherence to regulatory requirements and the closure of corrective action items.Qualifications: BS degree in Chemistry, Engineering, Life Science or related discipline required.ASQ CQA Certification or similar preferred.Experience in leading audits, writing reports and observation classification based on risk.Must have working knowledge of Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a drug product, medical device and combination product manufacturing operation.Exposure to Health Authority inspections.Must have direct experience with GMP compliance responsibilities, and Supplier Quality in pharmaceutical and/or medical device products.Must be able to partner and collaborate well cross functionally, at all levels.Must have excellent communication skills (verbal and written).Acts in a highly organized manner with a strong attention to detail, clarity, accuracy, and conciseness.A minimum of 3-5 years of relevant Quality Assurance experienceProficiency in MS software i.e. Word, Excel, PowerPoint, etc.#LI- JT1Up to 40% travel based on vendor requirements.

Travel Requirements

#LI- JT1

Up to 40% travel based on vendor requirements.

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 $73,000.00 to $97,200.00 per 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 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. 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.