QUALITY ASSURANCE PROFESSIONAL with extensive experience in the prescription and OTC drug development processes. Background includes quality auditing, clinical supply chain management and analytical chemistry. Knowledgeable regarding FDA, Health Canada and international pharmaceutical regulations, as well as medical device compliance requirements. Demonstrated ability to lead teams and collaborate cross-functionally. Skilled at negotiating and managing vendor relationships.

GCP QA Specialist @ Prepare, conduct, report and follow-up on audits of local and/or international clinical studies and related clinical systems and procedures, ensure that they are in compliance with applicable regulations, Good Clinical Practices (GCP) guidelines, and Company quality standards. Independently prepare, conduct, report, and follow-up on audits of clinical investigator sites, contract research organizations (CROs), and Company clinical systems, processes and documentation relevant to the area of clinical trials. Act as a GCP Project Representative (GPR) for assigned clinical projects. Train/Mentor others on CQA activities and other topics related to GCP, Regulations, and Guidelines, etc. Facilitate the preparation, implementation and periodic revision of CQA quality documents and working methodologies. Participate in Clinical Regulatory Inspections including preparation, escorting inspectors, and communicating information about inspection processes and results. From 2006 to Present (9 years) Manager, Quality Assurance & Compliance @ Ensured regulatory compliance for research and development R&D associates, consisting of the Analytical, Pharmaceutical Science, Early Compound Assessment, Regulatory Affairs, Project Management, Clinical and QA & Compliance departments. Assessed current quality systems and recommended improvements to enhance quality and reduce cycle time. Represented Quality Assurance on Development Project Teams, Pre-Approval Inspection Teams and Task Forces. Managed standard operating procedure (SOP) preparation, review, approval, revision and retirement process. Trained R&D associates on cGMPs, SOPs and company policies to ensure compliance with FDA, Canadian and European regulations. Represented department in the R&D Standards Group, which developed standardized SOP templates. Coordinated design change control activities from initiation to closure for all medical device products. Conducted internal quality systems and stability audits, which led to system improvements and procedure updates. From 2005 to 2006 (1 year) Manager, Quality Assurance & Document Control @ Developed and implemented policies, practices and procedures for efficient and standardized records management of existing hard copy and electronic records created within R&D. Managed the Central Files and archiving systems, development methods and specifications generation processes, and R&D documentation file system. Acted as site “point person” for document retrieval during regulatory and internal QA inspections. Issued internal audit reports, recommended corrective actions, addressed and followed-up on pending audit and inspection issues. Coordinated laboratory equipment calibrations and preventative maintenance, wrote procedures, and managed schedule (as R&D Calibration Committee Chairperson) to ensure laboratory compliance. Established Design History Files (DHFs) and Technical Files for all device products, which were referenced during GMED audits and FDA inspections. Ensured proper use of templates and forms. From September 2003 to December 2005 (2 years 4 months) Manager, Compliance & Clinical Supplies @ Partnered with global cross-functional project teams to represent/champion clinical trial materials product supply issues and ensured efficient, timely and cost effective delivery of project development milestones. Designed, planned, executed and managed supplies for clinical and non-clinical trials in collaboration with internal customers (including identifying risks and development of contingency plans). Ensured that clinical trial materials met regulatory criteria for all participating countries and that study-strategy aligned with global supply availability. Reviewed protocols, batch production records, packaging records, and results submitted from contract sites for completeness, accuracy and conformance to cGMPs/cGLPs/cGCPs. From 2001 to 2003 (2 years) Compliance Specialist @ Developed and maintained R&D associates training program and training record management. Reviewed and audited R&D associates' notebooks, training files, equipment logbooks, stability data tables, stability reports, OOS investigations and other items, as appropriate. Managed department SOP, guidelines and calibration procedure preparation, review, approval, revision and retirement processes. Maintained a log of all department OOSs and conducted trend analyses to identify trends and eliminate recurrences. Evaluated potential business partners and joint ventures for cGXP compliance. Assisted Lead Auditor when conducting audits/inspections at contract sites. Tracked and communicated all Pharmacopeial updates (i.e. USP, EP) as department representative of R&D Pharmacopeial Forum. From 1999 to 2001 (2 years) Senior Chemist @ Developed and validated analytical methods for NDA stability products. Prepared and submitted accurate, precise, and complete analytical reports. Worked as an intra/inter-departmental project team member. Provided analytical data for FDA briefing packages, analytical development summaries, CMC sections of Investigational New Drug Applications, Annual Reports, New Drug Applications, international submissions, and publications for scientific journals. Trained less experienced employees on analytical methods. Conducted feasibility studies to determine viability of products in development. From 1997 to 1999 (2 years) Chemist (contract position) @ Executed collaborative transfer studies to Quality Control laboratories at manufacturing sites. Conducted analytical testing on NDA stability products. Calibrated and performed preventative maintenance of laboratory equipment. Performed analyses of clinical and stability samples according to established protocols. Analyzed competitor products to assess possible patent infringement. Assisted Senior Chemists in methods development and validation. From 1996 to 1997 (1 year)

BS, Biology @ Penn State UniversityM.S., Pharmacy - Quality Assurance & Regulatory Affairs @ Temple University Dina Holland is skilled in: Regulatory Affairs, 21 CFR Part 11, GCP, CAPA, Pharmaceutical Industry, Sop, LIMS, GMP, Change Control, FDA, CRO, Validation, CTMS, Quality System Compliance, Training, GxP, SOP