Associate Director of Quality Assurance - Quality Assurance
Associate Director of Quality Assurance - Quality Assurance Apply
New York, NY
Full-time $166,000.00 - $210,000.00
Posted 05/14/2024
We are looking for a highly skilled Associate Director, CMC Quality Assurance.
We are a very accomplished team of industry experts with a mission to thoughtfully develop transformative medicines to improve patients lives with life-altering immune and inflammatory diseases. Our lead program has completed multiple phases 1 and Phase 2 clinical trials and we just launched out Phase 2b trial in thyroid Eye Disease in 2023 and Phase 2 clinical trial in cardiovascular disease in Q2 2024. We are looking to start our Phase 3 Clinical trial in TED later this year.
We are looking for an Associate Director, CMC QA will report directly to the Director of CMC Quality Assurance and will be responsible for the daily CMC operations included those performed at the CMO and CTLs that manufacture our products. You will also provide strategic leadership in support of continuous improvement, risk mitigation, and data integrity pertaining to the product manufacturing and quality management system to ensure a culture of quality and compliance
What you will be doing:
- Provide strategic leadership to develop, establish, and maintain the QA programs, policies, and procedures to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.
- Coordinate investigations with vendors and interdepartmental teams to resolve potential quality issues, mitigate risks, and ensure that appropriate corrective/preventative actions are identified and implemented.
- Support the management and continuous improvement of quality systems, including but not limited to supplier qualification, change management, product complaint management, quality management review, and deviation/CAPA management.
Must Have:
- BS/BA degree with a minimum of ten years experience or, MS/MA with 7 years of experience.
- Experience with 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 4 (Combination Products)
- Minimum 3 years of experience in CMO oversight is required
- Working knowledge of clinical manufacturing and quality processes, including US and EU regulations and ICH guidelines affecting the pharmaceutical industry
Base Salary Range: $166k - $200k
Applicants must be authorized to work in the U.S.
Job ID: MM41-
Employees will receive paid leave to the extent required by state or local law
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.
Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Copyright 1999 - 2024. CyberCoders, Inc. All rights reserved.
CyberCoders is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email . We will make a determination on your request for reasonable accommodation on a case-by-case basis. UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of CyberCoders.