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Manager, Quality Assurance
Insmed Incorporated San Diego, CA
Other 7 Months Ago
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Insmed Incorporated is Hiring a Manager, Quality Assurance Near San Diego, CA

Company Description

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Recognitions

Named Science’s 2021 Top Employer

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 2021 Top Employers Survey.

A Certified Great Place to Work

We believe we have built something truly special at Insmed, and our employees agree. Each day, we show up for each other and for the patients we serve. That’s why we were recently certified as a Great Place to Work in the U.S.

Overview

Insmed, Inc is seeking an experienced and motivated Quality Assurance (QA) professional with experience in Development QA Operations. The Manager, Quality Assurance will support the company’s quality and regulatory systems in compliance with industry best practices. They will focus on establishing, implementing, and maintaining quality operations systems that support product disposition. This is a full- time position reporting to the Associate Director, Quality Assurance and is located in San Diego, California.

JOB QUALIFICATIONS

Education, Certifications, Experience• Bachelor's Degree or equivalent combination of education and experience.• 5 years of experience in a quality compliance, quality assurance, quality systems, or quality control in pharmaceutical or bio-pharmaceutical field.• Demonstrated experience with phase appropriate GMP, investigation, and audit processes• Experience with batch record review and quality system documentation.• Experience in managing both internal and external records, quality-controlled documents, revision workflows and document change control processes.

Responsibilities

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

These include, but are not limited to:• Perform Quality Assurance activities to ensure compliance with established company and departmental policies and procedures, objectives, quality systems, and applicable regulations.• Develop, implement, and support quality systems processes and procedures.• Review and approve site SOPs and product specific master documents.• Review and approve Test Method and Process Qualification and Validation.• Review and approve Analytical GMP data.• Review executed batch records and documentation and conduct batch disposition of drug substance and drug product.• Facilitate and lead site change control committee.• Facilitate and report site Quality metrics.• Perform QA review and approval of Quality System documentation.• Review and approve external Vendor Quality Events, Change Controls, and CAPAs.• Process internal deviations, OOS investigations, CAPAs, and change controls.• Assist with the Vendor Qualification Audit Program for GxP contract service providers.• Support internal and external vendor qualification audits, as needed.• Support regulatory inspections and inspection readiness activities.• Work collaboratively with Sr. Management and other departmental functions.• Support daily operational activities onsite.• Other responsibilities and duties as assigned.

Qualifications

About You:

Knowledge, Skills and Abilities• Knowledge of GXP, SOPs, and quality system processes.• Excellent understanding of regulatory requirements.• Good verbal, written, and interpersonal communication skills are required.• Demonstrates working knowledge of Microsoft Office applications, Adobe, and SharePoint.• Excellent organizational skills and ability to review processes or procedures.• Able to take initiative and multitasking.• Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competenciesSPECIAL WORKING CONDITIONS

Travel Requirements

Up to 30% travel, both domestic and/or international, with periods of 50% and more travel.

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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Job Summary

JOB TYPE

Other

POST DATE

08/04/2022

EXPIRATION DATE

12/12/2022

WEBSITE

insmed.com

HEADQUARTERS

Bridgewater, NJ

SIZE

500 - 1,000

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If you are interested in becoming a Manager Quality Assurance, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Manager Quality Assurance for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Manager Quality Assurance job description and responsibilities

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Manager Quality Assurance jobs

When a product lacks quality, the customers are not happy and the business can suffer.

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Trained employees will be prepared to face problems and, therefore, can resolve them as soon as they occur and sometimes even before the customer can perceive the error.

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Acquire quality assurance knowledge of tools and methodologies.

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