Quality and Compliance oversight and end-to-end management of daily quality operations for key Contract Manufacturers in the North American region.

Provide oversight of quality and compliance for the manufacturing and packaging departments to ensure compliance to quality policies and regulatory requirements. Responsible for the management and support of Deviations/Investigations, Change Controls, CAPAs, Audits, Performance Management, Operational Documentation, Product Disposition decisions, and proactive compliance activities.

-Responsible for leading cross-functional investigations with Manufacturing, Packaging, and Engineering departments using the six-step approach to perform root cause analysis and define effective corrective and preventive actions.-Ensure product are produced in compliance with registered details, Technical Terms of Supply, regulatory standards, and company policies and procedures. -Responsible for leading system and department internal audits. -Support corporate and external audits. -Responsible for performing and writing Annual/Periodic product Reviews giving recommendations to the technical product owners for improvement based on data/trend analysis

-Responsible for the site's Supplier Quality Program which included performing qualifying and monitoring audits on raw material suppliers and service contractors-Performed Supplier Quality Risk Assessments. -Managed quality information records within the SAP system.-Maintained and authored Quality Assurance Agreements and Product Requirement Specifications for suppliers and service contractors. -Managed the review, revision and creation of Technical Terms of Supply - Technical agreements between the manufacturing site and international markets detailing quality responsibilities, regulatory and transport requirements. Worked closely with central regulatory and in market regulatory affairs to work on timelines for product registrations. -Responsible for performing and writing Annual/Periodic Product Reviews giving recommendations to technical product owners for improvement based on data/trend analysis. -Responsible for writing and updating Raw Material, Intermediate, Bulk and Finished Product Specifications, Packaging Test Methods and Master Manufacturing Instructions. -Performed Cleaning Validation Monitoring activities ensuring that current Cleaning and Sanitization Procedures remain in a validated state by analyzing the process as well as reviewing chemical residue and microbiological analysis. -Maintain Device Master Record for medical devices manufactured at the site. -Supported QA Operations with batch documentation review.

Responsible for reviewing batch records and executing product release. Responsible for performing Management Monitoring Audits. Documentation Deviations Metrics reporting. Responsible for tracking Non-Conformance Reports, Change Controls, and Laboratory Investigation Reports affecting batch release.

Responsible for overseeing all aspects of the Microsoft account relating to the transportation of goods and the maintenance of the client’s needs. Worked with Microsoft to establish detailed profiles and procedures that properly represented their order fulfillment and export process. Responsible for Customer Complaint Investigations. Created/Updated Standard Operating Procedures, Work Instructions, and System Training Guidelines.

Responsible for creating and revising re-packaging plans, rework plans, sub-assembly, and inspection plans. Reviewed, approved batch records, and executed product releases for the Merck Consumer Care/Bayer CH account making sure that they were in compliance with regulatory standards. Created and updated Standard Operating Procedures, and System Training Guidelines. Responsible for assigning/tracking Non-Conformance Report and Corrective and Preventive Actions for the Merck/Bayer account. Performed periodic internal audits and assisted with external audits (FDA, DEA, ISO, and Customers). Maintained current knowledge of regulations that affected the Pharmaceutical/Consumer Healthcare/Medical Device industry.