Manager, PSM Compliance

Establish and maintain all elements of the global compliance program. The objective of the Purchasing and Supplier Management (PSM) Compliance department is to develop and implement purchasing policies and procedures consistent with external (federal, state and local) and internal financial, quality and regulations and standards of performance worldwide. The primary function of this position is to document and ensure an adequate and effective Quality System is in place for PSM.


Key Responsibilities Include:

• The Compliance Manager applies risk management as an integral part of Purchasing and Supplier Management approach to compliance and ensures all risks (and impact of those risks) are communicated effectively to business partners.
• Manage the development, implementation, and maintenance of global purchasing policies and procedures. Establish and implement controls required for operation of purchasing functions. Responsible for mitigating and resolving issues supporting AbbVie internal policies and procedures and external compliance. Ensure PSM policy and procedure changes are aligned with financial, quality and other compliance objectives. Evaluate the impact of internal and external regulatory changes on Purchasing.
• Support all inspections, audits and the resulting action plans including implementation: External regulatory bodies such as FDA, DEA, ATF, EPA, ISO and US Customs; External financial institutions; Corporate Financial Audit; Divisional/ Corporate Quality and Regulatory Sciences audits.
• Perform periodic internal compliance reviews of the PSM Purchasing functions, delegated purchasing functions, and other groups performing purchasing related activities. Perform periodic internal compliance reviews of AbbVie's domestic Site Purchasing functions for compliance to the CFM and Purchasing Policies Issue reports and assist sites with development of corrective action plans. Provide support as needed to Security and Internal Audit in their investigations.
• Establish and maintain Purchasing Controls through policies, procedures, and training. Develop and provide PSM personnel with training on applicable regulations, policies, procedures and systems.
• Provide input to Risk Management, CDO, Finance, OEC, PTP and Quality as they develop policies, systems and activities that interface with purchasing functions.
• Maintain documentation as objective evidence to support compliance requirements. This includes implementation and monitoring of appropriate document change control systems, policies and practices. Participate in the global Purchasing Compliance Council including cross functional representation from Regional Purchasing, OEC, Legal, delegated purchasing groups, QA, Finance, etc.
• Manage the document change control process to ensure compliance with Quality System standards.
• Remain up to date in current regulations, quality, financial and OEC policies affecting PSM contract language and processes to ensure systems, processes, procedures, tools, contract templates and training appropriately reflect current global standards.
• Responsible for the development, management and implementation of global Purchasing SOP's, templates, and department specific work instructions. Responsible for holding PSM personnel and the functional areas to these policies to promote adherence and the development of Corrective Action Preventative Action (CAPA) plans for areas of noncompliance.

*Level of position is commensurate upon education and experience of the candidate.


Basic:

• Bachelor's Degree BA/BS degree Science, Business, Engineering, or Quality Science required or equivalent experience.
• 8+ years combined experience in a compliance management, purchasing, business operations, quality assurance, clinical outsourcing or contract management function. At least 2 years in purchasing, 1-3 years in quality systems or quality assurance, documentation, project or business management. At least 1+years' experience of business and commercial law. 2+ years project management experience desirable.
• The position must possess the ability to analyze both internal and external financial and other regulatory data and information to determine the impact on procurement and to assess and implement the appropriate action plans for the function.
• The incumbent is required to interface, both verbally and in writing with all levels of AbbVie employees (non-exempt to VP level). The incumbent communicates with suppliers with regard to regulatory issues.
• Interface with external auditing bodies and represent AbbVie.
• Strong written and verbal communication skills.
• Strong analytical skills being able to break down complex regulations into simple to understand instructions.
• Strong purchasing process and controls knowledge. Good planning skills.
• Ability to lead cross-functional project teams to help resolve issues and to drive process improvements.
• Expert knowledge/understanding of the business across the organization including business practices and policies relating to Purchasing, Finance, OEC, Quality, Legal as well as PSM processes, SOP's, international regulations, contract language requirements, and GxP.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled