Sharon Farrell Email & Phone Number

Ridley Park, Pa, Us

Raritan, New Jersey, Us

Global leadership role responsible for driving strategic partnerships and alliances for the Labeling Management technology product category and ensuring balanced harmonization between the people, process, technology and data that supports resolution of complex business scenarios. Establishes the vision for successful Labeling Management capabilities and mobilizes global, regional and local regulatory teams to achieve common goals that sustainably resolves compliance and business issues and ensures optimum operational efficiency through the use of innovative technology platforms. Serves as business product owner and drives the standardized use of the labeling information tracking system, ensuring effective and compliant harmonization with Global Labeling processes and applicable regional or local regulatory requirements.

Raritan, New Jersey, Us

Global leader with responsibility for driving strategic initiatives, including but not limited to, management of labeling change processes and systems, continuous improvement of processes related to compliance oversight of the end-to-end labeling process ensuring that labeling changes are implemented in a timely manner or escalated as appropriate. • Drives sustainable labeling compliance through risk identification and mitigation, leading quality investigations and developing CAPAs, leading Global Labeling contributions to audits and inspections, and ensuring process alignment with regulatory requirements/company standards. • Global Business Process Owner for Labeling Information for Tracking System, ensuring compliant harmonization between regulatory requirements, standards for system use, data integrity, and business support needs, including management of offshore vendor who provides ongoing global support to the business users.• Oversees Global Labeling monitoring of submissions process through establishment of the business rules and framework for compliance, provision of guidance for out of compliance situations, and driving process improvements that ensure ongoing compliance to the labeling processes.

Global leader with responsibility for partnering with GRA and Local Operating Company stakeholders, J&J Quality groups, and other functional areas as applicable to influence company best practice and drive strategic initiatives to deliver end-to-end continuous improvement of Labeling, Submissions Management and CMC processes. Responsible for oversight of compliance-related matters in the end-to-end processes within Labeling, Submissions Management and CMC, providing guidance and consultative direction to ensure adherence to regulatory and company requirements. Proactively assesses internal customer needs, analyses data and leverages business understanding to identify areas of potential compliance risk and drive strategic discussions with GRA leaders to align on prioritized action plans. Oversees the Quality Event Management process, audits and inspections, and development and maintenance of procedural documents, ensuring high quality and compliant process deliverables. Contributes to shaping an adaptable organizational model within the Quality & Compliance organization which meets the evolving needs of GRA for the future.

Global leader responsible for driving strategic initiatives which promote continuous improvement of the end to end labeling process to ensure that labeling changes are implemented in a timely manner or are escalated as appropriate. Developed and led the Global Labeling Compliance Monitoring and Oversight function responsible for ensuring compliance to regulatory and company standards for Company Core Data Sheets and locally driven safety changes.• Developed and led the change control and active monitoring processes for remediation of Janssen’s Retrospective Labeling Compliance Program, ensuring timely submission of labeling changes in remediation of identified discrepancies; resolved issues with the broader Program team and quality leadership as needed.• Led resolution of labeling compliance investigations and quality issues, including but not limited to, development and implementation of a streamlined process to ensure adherence to pharmacovigilance contractual agreements associated with labeling requirements for marketing partners.• Deployment lead for implementation of a global labeling tracking and compliance monitoring system, including establishment and engagement of global change agent’s network, development of deployment strategy, and collaboration with senior regulatory and quality leadership in endorsement of the approach.• Led development and implementation of Global Labeling Compliance competency model ensuring standardization of roles and alignment with Global Regulatory competency requirements.• Facilitation lead for global labeling-related internal audits and Health Authority inspections coordinating responses and ensuring timely and accurate provision of requests for information.

* Co-lead for Pharmaceutical R&D Training Council responsible for ensuring effective implementation of global enterprise-driven training initiatives and sharing of best practices among team members.* Design and implement sustainable training programs and events that ensure compliance to global pharmacovigilance regulations.* Lead and manage the transformation of GMO's global new hire onboarding process ensuring new employees become fully engaged in their new position including establishing a direct connection between their work, patient safety, and regulatory compliance* Led development of a Global Training Strategy positioning the training group to lead regulatory and systems changes within a fast-paced, dynamic environment.* Training lead for a Global enterprise safety system which includes system training program development, curricula design and implementation, trainer qualification, and training redesign for controlled document training e-Learning modules.* Developed training for J&J Global Medical Safety Standard ensuring common understanding of a harmonized vision and approach to cross-sector organizational alignment and resolution of medical issues.

New York, New York, Us

Directed the development and maintenance of a Global Packaging and Labeling Quality Management System, ensuring the creation of effective and efficient business processes, training programs, corrective and preventative action plans, and enterprise system designs that were compliant with Corporate policies, government regulations and/or guidelines, and industry standards. Selected Accomplishments: • Led development and maintenance of Wyeth manufacturing, packaging, and labeling policies, conformance standards and division directives affecting in excess of 50 facilities resulting in uniform global standards for regulatory compliance.• Directed change management and training programs associated with new or revised regulatory requirements, system implementations, and emerging business practices resulting in timely and compliant deployments. • Led Human Performance and Training Effectiveness audits of processes and systems resulting in the elimination of compliance gaps and improvements in the quality and efficiency of outputs.• Led cross-functional business and information technology teams in the development and implementation of an $85 million global enterprise-wide change control system that resulted in the elimination of 15 separate change control systems.• Developed global packaging specification, supplier quality, and incoming inspection standards systems resulting in the remediation of packaging-related consent decree commitments.• Led implementation of automated Packaging and Labeling Investigations/CAPA system resulting in the identification of improved cycle times and efficient integration with site Manufacturing investigations/CAPA.• Developed and implemented global SAP-based automated part numbering schema which resulted in the replacement of multiple site-based numbering schemes and contributed to the effective global rollout of SAP.

New York, New York, Us

Managed team of 14 package engineers, labeling project administrators, and graphic artists in the design, development and maintenance of packaging materials, bills of material, specifications and labeling.Selected Accomplishments:• Ensured on time delivery of packaging and labeling components for global new product launches for branded and generic businesses totaling in excess of $10 billion in annual sales.• Led design of new processes and procedures related to deployment of Technical Specifications System.

New York, New York, Us

Established satellite facility to support North American deployment of Technical Specifications System. Recruited, hired, trained, and managed a team of 20 contract package engineers in support of packaging documentation conversion effort.

New York, New York, Us

Supported deployment of $12 million Technical Specifications System as business client liaison ensuring system design was aligned to corporate and manufacturing site needs.Selected Accomplishments:• Established usage standards, assignments to teams, and provided user training.• Performed database administrator functions including workflow design and development, system maintenance, user provisioning, and support for IQ/OQ/PQ testing.

New York, New York, Us

Provided packaging project management support to Wyeth facilities related to new product launches and/or new packaging design implementations, ensuring on time delivery of specifications, labeling components, and bills of material. Coordinated efforts between package engineering, labeling, and manufacturing / packaging facilities.

Bachelor Of Science, Business Management With Certificate In Marketing

Masters, Business Administration; Marketing & Finance

Education record