Associate Manager, SMA

Integrated Resources, Inc in Foster City, CA

  • Type: Full Time
position filled
Job Title
Associate Manager, SMA

Department
PDM QA - Supplier Management and Audits

Job Responsibilities

Internal Audit Program and GMP Walkthrough

" Assist in the internal audit lifecycle activities for internal audits including scheduling, audit team assignment, audit preparation, audit agenda issuance, audit execution, drafting audit report and issuance, response/CAPA assessment and closure.
" Assist in managing contractors/consultants that support the Internal Audit Program. Ensure that they have the required skills, training and procedural qualification requirements including required consultant documentation
" Participate in the development, implementation and maintenance of procedures, systems and templates to assist in the Internal Audit Program.


Affiliates Audit Program

" Assist in the management of Client Affiliate Program including audit scheduling, audit team assignment, audit preparation audit agenda issuance, audit execution, drafting audit report and issuance, response/CAPA assessment and closure.
" Develop tools to improve efficiency and consistency in the Affiliates Audit Program
" Participate in the development, implementation and maintenance of procedures, systems and templates to assist in the Affiliates Audit Program.




Inspection Readiness Program (including PAI Readiness)

" Actively participate in designing an effective and holistic Inspection Readiness Plan for GSI FC and assist with drafting proposal for Sr. Management for review and approval
" Manages the logistics to support regulatory inspections at GSI FC including notification of management, key stakeholders, extended inspection readiness team (IRT), prep room and inspection rooms set-up and post inspection activities
" Assist in socialization of Inspection Readiness Plan to select key stakeholders and evaluate their feedback for incorporation
" Maintenance of inspection readiness tools including notification emails, playbooks, IR questionnaire, checklist and binders
" Collaboratively working with internal GSI FC key stakeholders regarding inspection readiness preparation activities including training and identification of inspection focus areas
" Assist in solidifying post-inspection activities including GTrack entries, CAPA tracking, lessons learned and response submission
" Develop and deliver training materials for inspection readiness
" Assist in putting together a GSI FC Master Inspection Binder including site master file, opening presentation, SOP list, inspection readiness team matrix , product/process stewards etc.
" Assist in finalizing and qualifying inspection support team members based on new roles and qualifications may include management proposal, interview, evaluation of current members

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