Damien Sharp Email & Phone Number

Washington, DC, US

Cambridge, Cambridgeshire, GB

• Responsible for the creation and implementation of a Software as a Medical (SaMD) Quality Management System (QMS) within AZ
• Contributes to the definition of the SaMD strategy in within AZ
• BPO for the Quality Management System for Software as a Medical Device QMS
• Contributes/leads significant local/cross functional or global projects/initiatives and influences decision making within Quality Assurance and the line functions/skills groups, including senior management
• Manages or leads functional input to global projects to deliver elements of the quality strategy/regulatory compliance.
• Front facing Subject Matter Expert for internal and external audits

Cambridge, Cambridgeshire, GB

• Responsible for ensuring and maintain compliance within the Computer System Validation (CSV) Program at AstraZeneca, AstraZeneca Biologics, Pearl Therapeutic, ZS Pharma, & Medimmune.
• Responsible for overall IT Quality and Compliance in the Americas Region for the following Business unitso Operations / Manufacturing Sites o Commercial and Sales & Marketingo Mergers & Acquisitions (Research and.
• Manage Direct Reports in the respective Americas Region
• Provide Mentoring and Training to Direct Reports and Cross Functional Team Members.
• Execute processes and procedures to assure the quality of IT systems and solutions
• Provide project and BAU leadership for regulated and critical business systems to ensure compliance with all applicable regulatory and operational requirements.

San Francisco, CA, US

• Implementing new Quality System Initiatives to address Consent Decree responses.
• Complete Annual Product Reviews in the External Manufacturing QA function.
• Compile product data for the review period – including batches manufactured, manufacturing and laboratory investigations, product quality complaints, adverse event, stability data, product quality returns, change.
• Review, Summarize and Generate a management report of product data.
• Ensure adherence to established SOPs for conducting and generating the Annual Product Review report.
• Function as the liaison with cross functional departments to ensure timely completion of APRs, per Johnson & Johnson / McNeil Consumer Products requirements.

Owings Mills, Maryland, US

• Responsible for establishing, implementing, and maintaining a quality system program according to the requirements of the various applicable domestic and international standards (GMP, QMS, and ISO 13485) for the.
• Responsible for reporting the performance of the quality system for periodic review of effectiveness and as a basis for improvement of the quality system to Executive Management via Management Review.
• Provided quality support to all manufacturing, product, and process development teams.
• Developed and Implemented policies and procedures essential to ensuring that all products and systems were in full compliance with all customer and applicable regulatory requirements.
• Ensured that new product development teams are supported for quality planning and verification and validation efforts as well as product sustaining engineering efforts
• Prepared and submitted applications to the FDA for marketing of Medical Devices 510(k).

San Francisco, CA, US

• Provide oversight to the Quality Assurance floor auditing function with emphasis on promoting a Right First Time methodology for manufacturing processes.
• Work with Production, Technical Service, Quality Control, and Validation management to perform identification of root cause(s), impact assessment, and the development of resolution strategies.
• Initiates investigations and provide final review on deviations and ensures timely notification of issues to customers.
• Assist with resolving all quality issues prior to product release.
• Mentors and develops Manufacturing and Quality Personnel through regular performance feedback and ensures performance management techniques are utilized throughout the site. Ensures all personnel are compliant with.
• Provides oversight to designated reviewers and approvers for manufacturing documents such as departmental SOPs, Change Control Requests and Batch Records.

Gaithersburg, Maryland, US

• Serves as a Subject Matter Expert (SME) responsible for assuring the quality of licensed products manufactured at MedImmune and contractors are in compliance with current good manufacturing practices by supporting.
• Company-Wide Cost savings of nearly $500K per year by the implementation of automation into quality systems management through TrackWise.
• Investigates, assesses and tracks the impact of minor and major excursions that may occur during manufacture, testing, or distribution of products or during the administration of quality systems.
• Identifies root causes, recommends and implements corrective actions to prevent recurrence.
• Reviews documents such as SOPs, deviations, VSCR (change control requests), corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval.
• Quality System Owner for the US-based and Rest of World (ROW) annual product review (APR) for the Synagis brand. o Performed a timely compilation of Annual Product Reviews by working with all functions areas.

Uxbridge, West London, GB

• Maintained Quality Assurance objectives in accordance with corporate policies and goals and as outlined in the Beverage Quality Manual, CCE Quality Manual and other source documentso Key Objectives included managing.
• Implemented inspection criteria and procedures in accordance to CCQS standards, the Beverage Quality Manual, CBQCM, HAACP, and local procedures.
• Effectively hired, trained, retained, deployed and engaged talent (training, development and performance management).
• Responsible for managing the day-to-day operations of more than 10 Quality Assurance Associates.
• Analyzed statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product.
• Assisted in the investigation and resolution of customer complaints and trends regarding quality.

US

• Developed and maintained Biosynexus’ Document Management System and Vendor Qualification and Agreement program.
• Established and maintained Corporate Master (Informed Consent) Schedules.
• Principal trainer for procedural and quality-related training and new hire orientation.
• Principal Inspection Coordinator for FDA Inspections.
• Ensured that documentation was in a state of compliance and audit/inspection ready at all times by the review, trend analysis of Batch Records, protocols and laboratory notebooks.
• Administered and managed the internal and external audit programs.

Tokyo, JP, JP

• Conducted day-to-day Corrective and Preventative Action (CAPA) operations including recording, compiling, tracking, and trending of CAPAs for all Shire US operations to ensure compliance to ISO 9000 Quality Management.
• Drafted and revised Standard Operating Procedures related to CAPA.
• Developed training modules and trained Quality Assurance (QA) new hires.
• Collaborated with Compliance Manager in the review of CAPA documents to meet Current Good Manufacturing Practices (cGMP) requirements.
• Provided guidance and leadership to more than four QA Compliance Associates in areas of Customer Complaints, Product Complaints, Annual Product Review, CAPA, and Product Release (Commercial and Clinical).
• Provided CAPA data for Annual Product Review (APR).

Tokyo, JP, JP

• Responsible for setting up, operating, maintaining, and cleaning processing equipment and facilities used in Technical Service and R&D projects.
• Provided technical support and training for the Production Department—Production Supervisors and Process Operators.
• Responsible for drug product transfer from one manufacturing site to another.
• Responsible for completing and maintaining a variety of documents required for cGMP operation and for project reports.
• Effortlessly executed project tasks per the direction of the Project Leader or Project Manager.
• Capable of working within a team of technicians, operators, management, as well as, members of other departments.

Tokyo, JP, JP

• Responsible for the manufacture of solid dose drug product utilizing Fluid-Bed Precision Processors, Pharmaceutical Spray Dryers, and High Sheer Granulators.
• Possessed a keen attention and aptitude in the administrative component of the industry--composing shift productivity updates, test document review, and deviations prior to product release.
• Able to set-up, operate, troubleshoot and maintain sophisticated pharmaceutical machinery.
• Served as an integral component for the development and training of new employees.

Associate Of Arts - Aa, Business Administration And Management, General

Bachelor Of Business Administration - Bba

Master Of Science - Ms, Biotechnology - Regulatory Affairs