Thomas Callison Cmq/Oe Email & Phone Number

Horsham, Pa, Us

Horsham, Pennsylvania, United States

Manage day-to-day operation of the corporate compliance program • Create a culture of quality and accountability among all employees to meet customer expectations • Serve as main point of contact for issue escalation and for managing overall client expectations • Ensure effective operational processes and procedures are in place to deliver contracted projects from project initiation through project completion • Serve, along with the project management team… Show more Manage day-to-day operation of the corporate compliance program • Create a culture of quality and accountability among all employees to meet customer expectations • Serve as main point of contact for issue escalation and for managing overall client expectations • Ensure effective operational processes and procedures are in place to deliver contracted projects from project initiation through project completion • Serve, along with the project management team, as key customer contact for compliance and data privacy-related issues • Author and maintain quality management system documentation •Initiate and drive continuous improvement across the organization • Act as the international data collection and data privacy liaison • Provide leadership in implementing and further developing quality and regulatory policies and procedures, in alignment with business objectives • Ensure application and study delivery is performed in compliance with industry expectations (21 CFR Part 11, GCPs, GDPR and others) • Author and maintain Clinical Ink’s customer communications library (RFI responses, audit questionnaires, et al.) • Conduct and provide support of customer and regulatory audits in conjunction with the Chief Business Officer • Perform duties designated for the role of Data Protection Officer in the EU GDPR, which include: o To inform and advise Clinical Ink employees of their obligations pursuant to the GDPR and other data protection provisions o To monitor compliance with GDPR and other data protection provisions including the assignment of responsibilities, awareness-raising and training of Clinical Ink staff Show less

Horsham, Pennsylvania

Direct oversight of Quality Management Systems, Government, and Life Science business units.

Horsham Pa

Strategic and detail oriented compliance and quality assurance executive with 22 years of proven Multi-channel customer engagement services and regulatory management in diverse pharmaceutical compliance and quality operations experience supporting pharmaceutical, medical device, electronics and publication manufacturing organizations.

Provide daily oversight for regulatory healthcare and life science compliance needs, affecting medical devices within a startup venture unit for Merck. Developed entire QSR system, ensuring compliance with 21 CFR 820 and ISO 13485. Reviewed executed and administered all documentation to include, policy procedures, training development and documentation control, with successful completion in (2) Merck audits of TransitionAdvantage, with no major findings. Continued oversight of all quality and… Show more Provide daily oversight for regulatory healthcare and life science compliance needs, affecting medical devices within a startup venture unit for Merck. Developed entire QSR system, ensuring compliance with 21 CFR 820 and ISO 13485. Reviewed executed and administered all documentation to include, policy procedures, training development and documentation control, with successful completion in (2) Merck audits of TransitionAdvantage, with no major findings. Continued oversight of all quality and compliance initiatives within the unit, ensuring regulatory and internal adherence. Project lead to develop privacy and security posture to ensure HIPAA compliance, as a Business Associate, working with cross-functional partners and Merck Privacy Office. Show less

Ivyland

Oversaw ISO 13485 standards and QSR regulatory compliance, for a well established automated endoscope reprocessing (AER) manufacturer. Continue to developed and improve conditions of the QMS by interfacing with product development groups to ensure that design inputs, verification and validation testing meet or exceed domestic and international regulatory expectations. Create, write, administer and approve all internal/external quality documents. Quality inspect all internal manufacturing… Show more Oversaw ISO 13485 standards and QSR regulatory compliance, for a well established automated endoscope reprocessing (AER) manufacturer. Continue to developed and improve conditions of the QMS by interfacing with product development groups to ensure that design inputs, verification and validation testing meet or exceed domestic and international regulatory expectations. Create, write, administer and approve all internal/external quality documents. Quality inspect all internal manufacturing processes and products. Collect and analyze quality data to develop and maintain trends throughout the product life cycle. Monitor and measure the QMS to ensure manufacturing goals and expectations are met through quality metrics on a monthly basis. Manage CAPA process to ensure compliance, identify any nonconformance and perform root analysis. Show less

Ivyland, Pa 18974

Promoted from Operations Manager to oversee core business and operational development functions (e.g. purchasing, human resources, finance, quality control, quality management, ISO 9001:2000 certification) within Return Merchandise (RMA) handling center and (FA) failure analysis services. Directly supervise staff of 20 employees to support major contracts with SONY, Toshiba, DELL and IBM/LENOVO Recall projects.

Tasked by executive management to: Supervise staff of 30–45 employees comprised of data entry operators, quality inspectors, and clerical personnel involved in producing the conversion, management, and pre-press publication needs of clients. Administered company policies and procedures. Created daily statistical and United States Patent and Trademark office reports that are updated by all facilities, used to monitor production throughput per the USPTO’s forecasted requirements. Applied… Show more Tasked by executive management to: Supervise staff of 30–45 employees comprised of data entry operators, quality inspectors, and clerical personnel involved in producing the conversion, management, and pre-press publication needs of clients. Administered company policies and procedures. Created daily statistical and United States Patent and Trademark office reports that are updated by all facilities, used to monitor production throughput per the USPTO’s forecasted requirements. Applied statistical processes to ensure quality and quantity metrics- were met daily as well as managing employees, set goals, and provide feedback on monthly production reviews and individual performance. Show less

Master Of Science - Ms

Bachelor'S Of Science

Education record