Supplier Quality Associate

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 experience
• Proficiency in MS software i.e. Word, Excel, PowerPoint, etc.

Travel Requirements

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 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 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.