David Feria Email & Phone Number

Wayne, Pennsylvania, Us

Watertown, Massachusetts, Us

Responsible for the strategic direction and leadership for GMP Quality Operations, overseeing manufacturing and CMC related quality activities from clinical development through commercialization. Skilled in leading cross-functional teams to drive continuous improvements and streamline processes based on process risks applicable to the clinical and commercial product phase:• Spearhead the development and implementation of quality strategies for FDA-regulated combination products, ensuring alignment with company objectives and regulatory requirements.• Collaborated with cross-functional teams to identify and mitigate risks associated with product development, manufacturing and supply chain activities.• Provided quality guidance for the transition from clinical to commercial product, including establishment of new manufacturing facility, PPQ and PAI readiness planning.• Fostered a culture of quality and compliance, mentoring and supporting individuals across the organization.

Cambridge, Massachusetts, Us

Develop and establish Quality Management Systems to transform a CRO based donation process into a GMP inspection ready program. • Provides quality guidance and support for Donation Collection Facilities and Donation Operation's projects and programs, ensuring compliance with regulations and internal policies. • Develops and leads on-going quality oversight visits at donation centers, ongoing Quality Management Review meetings and develops audit plan for donor collection centers, testing laboratories and for Donation Operations. • Prepares quality oversight plans, checklists and summary reports for leadership. Ensures follow up activities are completed within timelines.• Assists with investigations and CAPA for Donation Operations deviations.• Attends ongoing operations meetings, medical review meetings of donors and performs detailed record reviews to support the Certificate of Conformance for Starting Raw Material.• Leads Donor Review Committee and maintains all supporting documentation and decisions.

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Boston, Ma, Us

Conducting compliance audits at company facilities on a worldwide basis. Responsibilities include planning and conducting assigned audits of specific sites, products, processes, or areas to assess compliance status with applicable regulations, standards and internal requirements. Supports manufacturing sites with training and guidance in establishing best practices.

Silver Spring, Md, Us

• Conduct regulatory inspections and investigations of various establishments specific to biologics, medical devices and electronic product radiation controls. • Plan and conduct inspections and investigations analyzing significant facts. • Perform analyses and evaluation on data samples and documented information gathered during inspections and investigations in order to ensure that documentation and practices are in compliance with Federal laws, rules and regulations. • Prepare concise factual reports reflecting significant observations.• Survey and follow-up with non-compliant industry establishments. • Serve as an instructor with responsibility for providing on-the-job training to acquaint lower graded trainees with sophisticated techniques employed in establishment inspections and investigations.• Provide feedback or information that is often utilized in administrative hearings and judicial proceedings.

Washington, Dc, Us

• Program expert for Electronic Records and Signatures (21 CFR 11), electronic systems and equipment validation, and implementation of College of American Pathologists’ Biorepository Accreditation standards.• Developed and implemented MAVERIC’s Study and Sponsor Assessment Program to ensure compliance with study protocols, ICH Good Clinical Practice, VHA rules and applicable guidelines and regulations (FDA, HHS, NARA) for each study coordinated by the MAVERIC Cooperative Studies Program Coordinating Center (CSPCC). • Manage the MAVERIC Study and Sponsor Assessment Program.• Member of the work team responsible for implementing ISO 9001:2008 for the VA Cooperative Studies Program.• Quality lead for obtaining CAP Biorepository Accreditation for the MAVERIC Biorepository.• Perform quality management activities, including document review and approval, change control, incident management and training.• Consult and partner with the clinical program team to provide compliance guidance across investigator sites, vendors, and internal processes. Provide functional review of clinical protocols, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents.• Develop site specific and study specific corrective actions and training where appropriate with external monitoring and auditing groups. • Provide regulatory guidance and input for prospective new or revised CSP policies or procedures.

• Plan, lead and execute independent internal audits to assess the internal control framework for all processes within Biomedical Services division. • Prepare detailed written reports of internal control issues for Audit Services management, American Red Cross Biomedical Services Headquarters and the Board of Governors.• Serve as the primary subject matter expert in blood banking and laboratory regulatory and accreditation requirements, including FDA, OSHA, DOT, AABB, ICH, ISO and EU regulations/accreditation within the Audit Services department.• Interpret and communicate regulatory and accreditation requirements to management to support the revision of existing procedures in response to changing regulatory requirements.• Serve as a subject matter expert and organizational resource for project management, including process mapping, validations and process improvement.• Serve as a subject matter expert and organizational resource for problem management, including root cause analysis, corrective and preventative actions and effectiveness checks.• Serve as a quality and regulatory subject matter expert and resource on numerous project management teams.• Consult with department management and staff on methods of developing and improving existing internal controls to support achievement of business objectives.• Utilized the audit program as a tool for the education and training of departmental staff and management on regulatory requirements throughout the organization to assist in cultural awareness and improved support of quality in daily activities.

Bristol, Gb

• Managed all equipment and process validation protocols and reports for the move to and set-up of the Filton Supercentre (a multi-million dollar manufacturing and testing facility consolidating and expanding all operations in the southwest United Kingdom).• Successfully managed validation activities to implement the newly consolidated product receipt, manufacturing, storage, testing and transport facilities at the Filton Supercentre.• Successfully managed validation activities to move and consolidate the Red Cell Immunohaematology; Histocompatibility and Immunogenetics; Stem Cell Immunotherapy; and International Blood Group Reference laboratories, including new clean rooms and CL3 research labs, at the Filton Supercentre.• Planned and performed internal audits in anticipation of external regulatory inspections and to satisfy GMP requirements focusing on local issues with implications for national organization. Communicated the results in written reports and oral presentations to upper management.• Participated in the implementation and management of national initiatives and QA projects.• Provided quality consultancy and support to projects throughout the National Health Services Blood and Transport, ensuring that project outcomes complied with licensing and accreditation requirements.• Interpreted and communicated regulatory and accreditation requirements to management on revision of existing procedures to meeting changing regulatory requirements, including MHRA, EU, FDA, AABB, ICH and ISO.• Collaborated in application of accreditation and best practice guidelines to NHS blood products and services. Communicated best practices to relevant staff. Participated in strategy development within the National Quality Systems Development Team and assisted the Head of QA in developing and delivering a Quality Strategy that promoted a common national approach and commitment to quality and quality improvement.

Indianapolis, Indiana, Us

• Created, managed and reviewed project and validation plans for implementation of new equipment and processes across the organization.• Managed the internal and external audit program for Indiana Blood Center to include, but not limited to, all departmental, process, system and follow-up audits for all locations across the state.• Implemented and supervised training program for integration of operational department staff into audit program to increase awareness of quality techniques and improve impartiality of internal quality system audits.• Developed, implemented and maintained new and existing quality system policies and procedures, including standardization of audit procedures and department responses to corrective actions.• Developed, tracked and reported quality metrics to identify potential areas of quality and regulatory concern within the organization.• Maintained subject matter expertise in regulatory requirements and accreditation requirements, including FDA, OSHA, DOT, AABB, ICH, ISO and EU.• Interpreted and communicated regulatory and accreditation requirements to management to facilitate revision of existing procedures in support of changing regulatory requirements.• Served as a subject matter expert and organizational resource for problem management, project management, process mapping, validations and process improvement.• Consulted with department management and staff on methods for developing and improving existing internal controls to support achievement of business objectives.• Utilized the audit program as a tool for the education and training of departmental staff and management on regulatory requirements throughout the organization to assist in cultural awareness and improved support of quality in daily activities• Completed statistical analysis for newly acquired instrumentation and the correlation of applicable testing instruments. Provided statistical support for research presented at national industry meetings (AABB, ASHI).

Indianapolis, Indiana, Us

• Developed, implemented and maintained a comprehensive training program to ensure technical laboratory staff responsible for viral testing, immunohematology and HLA/DNA activities were properly trained to perform assigned tasks in accordance with policies, procedures and regulations• Developed, implemented and delivered training programs for new hire and annual organizational training that was accessible and meaningful for a variety of end user groups (multiple locations, multiple departments and varied educational backgrounds).• Performed periodic assessments of the existing training system for process improvement, implementing appropriate revisions to proactively address potential system weaknesses.• Served as a subject matter expert and resource on project management teams to ensure training requirements were met.• Performed regular audits of viral testing, immunohematology and HLA/DNA lab training files for incorrect or missing documentation and file completeness.

B.S., Psychology, Microbiology

Education record