Carol Winnefeld Email and Phone Number

Provide quality strategies and operational excellence to ensure safe, compliant and integrated quality management of the Clinical Trial Division (CTD) within Thermo Fisher Scientific. Coordinate global policy/SOP development and coordinate within CTD, lead the global change control for the division, evaluate metrics/trends within the division (including management of quality and business reviews) and provide recommendations, as needed. Assist with coordination of strategic and operational decisions within CTD, including maintenance of quality plans. Support the overall Quality (Technical) Agreement process within CTD, including drafting and negotiation with internal and external clients, including those involving PSG's Integrated Service model.

Leads a team of Quality professionals who will draft, negotiate and administer Quality (Technical) Agreements in accordance with applicable organizational and departmental policies and procedures.Ensure that Quality Agreements meet the same established quality standards and requirements.Coordinate systems and procedures related to processing of Quality (Technical) Agreements, including review processes for quality provisions. Collaborate with the Contracts Team to assist if necessary with the assembly of the final contract package for each customer/supplier and/or project.Perform Quality related risk assessment of proposed QA/GMP related Quality (Technical) Agreement provisions and develop recommendations to minimize their potential risk to the business.Track and report on Quality (Technical) Agreement statuses as required. Collaborate with Contracts to ensure accuracy on statuses.Assist in defining, establishing and implementing quality assurance/control procedures for Quality (Technical) Agreements, storage and compliance monitoring.Independently lead/participate internal/external GMP/Quality compliance audits as well as regulatory inspections. Provide GMP compliance expertise to internal and external customers.Apply Good Manufacturing Principles in all areas of responsibility.

Responsible for establishment and alignment of new external contract manufacturing within the organization,review, establish and update standard operating procedures and/or quality assurance documents,liaison between internal and external quality groups, verify that materials, purchased parts or components, in-process samples, and finished products meet established testing and specifications, identify quality problems or areas for improvement and recommend solutions, direct the tracking of defects, test results, or other regularly reported quality data. communicate quality information to all relevant organizational departments, outside vendors, or contractors, prepare Quality Agreement documents for both client and internal use, evaluation supplier performance and issue/evaluate investigative reports to ensure supplier maintains an adequate level for business requirements, provide quality guidance to departments or project teams regarding evaluation of products, formulate or implement external contracting procedures to ensure that regulatory compliance is maintained, manage activities such as external audits, regulatory agency inspections, or product recalls, maintain current knowledge of relevant regulations, including proposed and final rules.implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.oversee documentation efforts to ensure compliance with pharmaceutical regulations and standards, establish quality related priorities and allocate resources and workloads.

Negotiated Quality Agreements between Baxter and our contract manufacturers. Prepare quality related contractual documents, including legal correspondence, as applicable.Meet with clients to discuss details of contracts.Negotiation quality related provisions, including regulatory requirements, with client.Organize and maintain documents in appropriate paper or electronic filing system in order to maintain compliance with governmental regulatory requirements.Review all quality agreements to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.Communicate quality agreement information to multiple departments and ensure that information is interpreted correctly.Manage activities such as audits, regulatory agency inspections, or product recalls.Develop and maintain standard operating procedures or local working practices.Train staff in quality agreement related policies or procedures.Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

Managed overall batch release and exception timelines, assisted with exception report review/approval, assisted with audits, interacted with the regulatory agencies during GMP inspections, including drafting/approval of responses and CAPA.

Managed a staff of approximately 25 personnel in varying responsibilities of batch review, exception review, calibration, regulatory/client audits and GMP oversight.