SAP Quality and Compliance Consultant

2 weeks ago

Wisconsin Dells, United States Softworld Inc Full time

Job Title: SAP Supply Chain Quality and Compliance Subject Matter Expert (SME)

Location: Science Drive Madison WI 53711 (Possibility of remote if they can access via VPN)

Onsite Requirements:


SAP Supply Chain Compliance and Regulatory knowledge and experience, should know SAP QM/QC, MM, PP, etc.
Depth knowledge of FDA regulatory guidelines, CFR Part 11, GMP/GxP/GAMPand other life science/pharma/bio-tech regulatory and compliance standards.
Consulting/Advisory mind-set to assess-evaluate existing SCM applications.

Position Overview:


The Sr SAP Quality and Compliance Consultant will play a pivotal role in evaluating and assessing our bio-technology clients' Supply Chain applications' existing quality, compliance, and regulatory processes.
Your primary responsibility will be to identify areas for improvement and provide strategic recommendations to enhance efficiency, effectiveness, and regulatory compliance.

Key Responsibilities:
Comprehensive Evaluation:


Conduct thorough evaluations of current state SAP supply chain applications, with a focus on quality management, compliance, and regulatory processes.
Assess the alignment with FDA regulations, CFR Part 11 requirements, GxP/GMP compliance, and other relevant standards within the pharmaceutical and biotechnology industries.

Process Analysis:


Analyze existing quality, compliance, and regulatory processes across the SAP supply chain, including distribution and procurement applications.
Identify inefficiencies, gaps, and potential risks within the supply chain processes.

Gap Identification:


Identify gaps, deficiencies, and areas of non-compliance within the SAP supply chain applications and processes.
Perform detailed gap analyses to pinpoint discrepancies and areas requiring enhancement to ensure regulatory adherence and operational excellence.

Recommendations and Strategic Solutions:


Develop actionable recommendations and strategic solutions for improving the quality, compliance, and regulatory aspects of our clients' SAP supply chain applications.
Propose innovative approaches to address identified gaps, streamline processes, and enhance regulatory compliance while optimizing supply chain efficiency.

Implementation Support:


Provide hands-on support and guidance during the implementation of recommended improvements and solutions.
Collaborate closely with our clients' teams to ensure seamless execution and integration of proposed changes.


Training and Knowledge Transfer:


Deliver training sessions and workshops to educate our clients' stakeholders on quality management, compliance, and regulatory best practices within SAP supply chain applications.
Facilitate knowledge transfer to internal teams to empower them to sustain improvements and foster a culture of continuous improvement.

Qualifications:


Bachelor's or master's degree in supply chain management, Business Administration, Information Technology, or a related field.
10+ years working in SAP Supply Chain consulting or advisory roles, preferably within the pharmaceutical or biotechnology industry.
In-depth knowledge of SAP supply chain, distribution, and procurement applications, along with proficiency in regulatory compliance standards such as FDA regulations, CFR Part 11 requirements, GMP standards, and GRC principles.
Strong analytical skills with the ability to conduct comprehensive evaluations, process analyses, and gap identifications.
Excellent communication and interpersonal abilities, with a demonstrated aptitude for building rapport with clients and stakeholders.
Proven track record of delivering value-driven recommendations and strategic solutions that drive measurable improvements in operational efficiency and regulatory compliance.

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