SAP Quality and Compliance Consultant at Softworld Inc

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.