Senior Auditor, Audit Management

Company: CSL Behring
Location: Holly Springs
Posted on: May 15, 2022

Job Description:

Job DescriptionJob Purpose:Responsible for the aspects of GMP/GxP audits of vendors, internal sites, and contract manufacturers, assessing compliance with regulatory and Seqirus requirements, to provide quality oversight and guidance to identify quality risks, assess severity, and facilitate appropriate mitigations to ensure compliance and continuous improvement at each of the manufacturing sites.This individual is also responsible to support the harmonization, maintain and enforcing global audit strategy, processes, practices, and SOPs that are consistent across the manufacturing sites.Major Accountabilities:

• Provides support for the preparation and execution of supplier and internal audits to verify compliance with global GMP regulations and corporate requirements
• Support to develop quality policies, procedures and standards governing and harmonizing of the global audit and inspection program for all Seqirus sites.
• Assist in the development of a global audit program and schedule in collaboration with other sites.
• Ensure that all audits and inspections are performed as per plan (either internally or by a 3rd party contractor).
• Assist to co-ordinate and execute supplier audits including inspections of CMOs/ Vendors/ distributors/ laboratories and service providers
• Participates and Support in Regulatory inspections at Seqirus sites
• Provide support and subject matter expertise to manufacturing sites, clinical sites and CMOs in preparation for regulatory inspections
• Participate in inspections to understand root causes behind quality issues
• Communicate identified quality issues globally to avoid repeated issues
• Track inspection responses and commitments to Regulatory agencies (Health authorities) across at assigned site.
• Maintain processes, procedures, and SOPs for auditing and inspections
• Partner with stakeholders to assist to develop and communicate innovative, compliant solutions using a risk based approach for internal and external inspections
• Support the global model for corporate audits (bi-annually) to identify weakness in cGMP systems.
• Support to develop in principles of auditing and inspections.
• Ensure to upkeep accreditation, qualification to perform required inspections and adhere to processes and SOPs ensure inspectors are trained and accredited
• Maintain and update processes, procedures, and SOPs based on continuous improvement for conducting both internal and external audits
• Maintain and share knowledge of Regulations and Requirements
• Stay current and up to date with any regulations and requirements related to audit management as well as industry/regulatory trends in this area
• Identify and/or create new requirements for Seqirus to ensure a high level of quality; communicate new Seqirus requirements internallyMinimum Requirements:
  • Bachelor's degree in science or engineering discipline Advanced degree is preferred.
  • Minimum of 3 years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred. years of experience preferred.About UsOur BenefitsSeqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.About SeqirusSeqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus .We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.Do work that matters at Seqirus!

Keywords: CSL Behring, Cary , Senior Auditor, Audit Management, Executive , Holly Springs, North Carolina