Sr. Auditor, External Supplier Quality
4 weeks ago
This position sits onsite 3 days weekly at one of the following locations: North Chicago, IL; Irvine, CA; South San Francisco, or Ludwigshafen, LU.
Purpose:
Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide
Responsibilities:
Carryout job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies
Independently plan and conduct internal system audits and external GxP supplier audits
Maintain approved supplier list, global audit schedule and participate in supplier management processes
Gathers internal and external audit metrics and presents to QA management for trend analysis
Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
Provide guidance and training on GxP regulations and guidelines to GxP auditors and functional areas personnel
Assist GxP QA Management on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers
Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities
Expected to elevate any issues to management, as necessary, in meeting these responsibilities. Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight
This is an experienced level compliance position that reports to the Associate Director GxP Compliance. This individual is expected to identify and resolve problems, through effective interpersonal skills. The incumbent will work effectively independently,
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