Manager, Supplier Qualification, Auditing

Job Title: Manager, Supplier Qualification, Auditing

Job Number: 83756

Location: , US

Job Description

As Manager in the Global Supplier Quality team, you will oversee GMP and IT audits, including supplier, contract manufacturing, contract testing, and partner audits across commercial programs and clinical trials.

Responsibilities

* Manage the audit lifecycle: scheduling, planning, conducting audits, issuing reports, and ensuring timely closure of findings. * Oversee audits conducted by contracted auditors. * Support trending and analysis of audit observations. * Maintain the Approved Supplier List (ASL) and Audit Plan. * Collaborate globally to align and standardize audit and vendor qualification practices. * Track and report auditing and vendor management metrics to management. * Gather and report metric information for continuous improvement efforts.

Required Skills

* Bachelor’s degree with 8+ years in Quality Assurance within a regulated environment and 5+ years as a lead auditor. * Strong knowledge of GMP operations, manufacturing, and testing for Cell or Gene Therapy. * Developed understanding of global compliance trends and ability to apply risk management in audits. * Excellent communication, organizational, and interpersonal skills. * Self-motivated, detail-oriented, and adaptable to fast-paced environments. * Willingness to travel up to 60%.Preferred:  * Experience with virtual and onsite audits; ASQ-CQA or similar certification. * Familiarity with regulations like 21 CFR, EudraLex, USP/EP, ICH, and ISO standards. * Experience with e-systems/tools and knowledge of Quality by Design (QbD). * German language skills.#LI-DNI

Application Deadline: 2024-09-30