Senior Pharmaceutical CDMO Quality Analyst

Description

Our Contract Development and Manufacturing Organization (CDMO) requires a seasoned Managing Quality Professional with more than 10 years of experience in pharmaceutical manufacturing, specializing in areas such as sterile processing and visual inspection. The candidate will be instrumental in upholding our commitment to excellence by leading our external Quality teams in ensuring our products not only meet but exceed quality standards.

Job duties :

• Develop and enhance relationships with CDMOs to effectively build a collaboration and partnership.
• Provide Direct supervision and enhancement of the Quality Management System (QMS) to assure consistent adherence to cGMP, CFR, USP, & ISO quality standards (Other world-wide regulatory requirements experience preferred).
• Manage Padagis Source Approval process to bring new CDMOs into the Padagis Quality Management and Enterprise systems.
• Independently Scope, Plan, Schedule, and Perform auditing of CDMO as Lead Auditor, issuing observations and approval of observation responses.
• Formulate and enforce quality protocols and procedures, aiming to optimize product quality and reduce quality-related risks.
• Govern sterile processing operations to maintain sterility assurance levels and conform to aseptic principles.
• Supervise and refine visual inspection processes to guarantee all products meet USP and FDA requirements.
• Spearhead investigations into quality events, discrepancies, deviations, and customer complaints, implementing swift and effective CAPA measures.
• Lead Quality and Technical aspects of drug product Technical Transfers of products from CMO to CMO or CMO to into Padagis internal systems.
• Review and approve CDMO documents (i.e. deviations, change controls, protocols, reports, etc.).
• Author and Lead Quality Assurance Agreement development and collaborate with the CDMO, Padagis Legal, Regulatory Affairs, and Pharmacovigilance Teams to complete this Agreement with no impact to overall product launch schedule.
• Work robustly with various teams such as Regulatory Affairs, R&D, Operations, and Supply Chain to embed quality considerations throughout all stages of product development and lifecycle phases.
• Mentor and cultivate talent within the Quality department, promoting a culture rooted in excellence and responsibility.
• Provide support to CDMO during and after FDA inspections and support them in observation responses and remediation of any observations.
• Support and provide QA and Technical direct input to Padagis Legal Team for matters involving CMO and / or externally manufactured Padagis products.
• Other duties as assigned.

Minimum qualifications :

Preferred qualifications :

Core Competencies;

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five "core" competencies. We strive to bring employees on board the journey with us who exemplify these key competencies :

About us :

At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in "extended topical" medications, like creams, foams, mousses, gels, liquids and inhalable products. It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

What's Next :

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

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