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  Supports the strategic auditing direction for Suppliers, Third Party Manufacturers (TPM), manufacturing sites and affiliates.

• Supports the global audit program and schedules for Suppliers, Third Party Manufacturers (TPM), manufacturing sites and affiliates. Assist in making sure Supplier, TPM, sites and affiliates are periodically audited to assess compliance to applicable regulations and identify potential risks.

• Assists in establishing effective global auditing goals through risk management and stakeholder alignment.

• Assists as the subject matter expert on all division policies and procedures related to auditing.

• Stays up to date on current regulatory requirements, standards, proposals, and best practices via constant surveillance of governmental publications, attending GMP/FDA/Food Safety seminars and meetings. Disseminates regulatory requirements to appropriate personnel as applicable.

• Alerts management of quality and compliance risks, including making sure applicable elevations are done through the management review meetings.

• Implements and maintains an effective Compliance and audit program. The auditing function assures compliance through various programs.

• Providing and executing annual schedules by assessing compliance of the systems and facilities.

• Providing feedback in the form of audit observations, formulating recommendations, and determining if corrective actions and commitments have been properly implemented and are effective.

• Leads and participates in continuous improvement program and certification for Safe Quality Foods (SQF), Food Safety System Certification (FSSC), International Organization for Standardization (ISO), Halal, Kosher and Organic.

• Owns and resolves effectiveness verification related to global quality compliance

Minimum Education/Professional Experience:

Required:

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  Education: Bachelor’s degree in applied, physical, or life science, engineering or business. Master’s degree preferred.

• A minimum of 5 years of experience in Quality, Research and Development (R&D), Supply Chain and Manufacturing, or related experience is required. Experience working with plants, R&D, supplier, TPM, regulatory and affiliates is preferred.

Preferred:

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  Candidate must have demonstrated leadership skills/competencies with track record of success with no less than five years of supervisory management experience.

• Knowledge of applicable regulatory standards and GMP requirements used in manufacturing of conventional foods, infant formulas, medical foods, and foods for special medical purposes (FSMP)

• Expert knowledge of quality management systems and regulatory requirements. Certification in FSSC, SQF, ISO is a plus.

• This position requires excellent problem solving and decision-making skills since the technology for many of Abbott's products are unique.

• This position requires a thorough understanding of integrated processes and technologies involved in supply management is required.

• The manager must have the ability to work and interact with many cultures in many time zones and be capable of interpreting and analyzing technical data from different regions for decision making. The manager must have the ability to summarize and present technical recommendations and solutions to Abbott senior management

• Able to effectively manage project resources and stakeholder management

• High customer orientation and sense of ownership and strong focus on business outcomes

• Able to make decisions that impact project level activities and influence project level budget

• Able to interact and contribute effectively with others in a team

• Possess excellent communication and interpersonal skills

• Proficient in MS Office such as Outlook, Word, Excel, PowerPoint