Elie Arslan, M.S., Mba Email & Phone Number

San Diego, CA, US

San Diego, CA, US

• Held various leadership roles since August 2022 starting as Associate Director of QA, to head of QA, Facilities and Program Management and recently Associate Director of Quality and Program Management (Head of Quality.
• Established a phase appropriate risk-based Quality Systems for R&D, nonclinical and early clinical phases
• Oversee QA & QC Microbiology activities
• Oversee Cellics' training program and gown qualification using TalentLMS.
• Oversee vendor audits (GMP, GCP and GLP) for CROs and contract test labs, R&D vendors, and oversee internal audit programs.
• Oversee Document Control and host periodic Management Reviews.

San Diego, CA, US

• Ensured successful qualification/certification of clean rooms
• Oversaw facilities for 6 months and ensured facility permits were renewed.
• Reduced ~$15,000 on equipment maintenance/services by negotiating with vendors and reduced facility costs.
• Managed two programs by building and maintaining master timelines, ensured timely input from stakeholders, co-led efficient Project Team meetings and raised key issues and opportunities to drive program goals.

San Diego, CA, US

• Established phase appropriate Quality Systems following GMP and GCP guidelines for Phase 1/ Phase II clinical studies.
• Ensured all deviations of GMP batches were addressed and closed by Q4 2022.
• Established change control program, CAPA program, Deviation process, vendor management program, material management program and internal audit program. Ensured 95% of key Quality System procedures are created by Q4 2022.
• Managed QA department budget.
• Performed vendor and internal audits (GMP, GLP and GCP)

San Diego, California, US

• Successfully managed a large team of Document Control and Technical Quality Groups with functions such as Document Control requests, Document Periodic reviews, ACE reviser role training, change control management.
• Attended monthly meetings and provided feedback in the Leadership Team.
• Improved KPIs of equipment PMs, and calibration with facilities and engineering group.
• Supported compliance team with client audits & Quality Management System.
• Co-hosted a successful FDA PAI inspection in May 2021. EIR received in August 2021.
• Co-hosted a successful Russian Regulatory Inspection in 2021.

• Managed cGMP disposition of patient specific and neoantigen shared gene therapy clinical products and shipments (both domestically & globally following GDP / GCP).
• Performed client batch release following GMP, GCP and GDP.
• Successfully managed and completed the GMP Tech Transfer project with a client.
• Improved KPIs for Quality Systems. Over 90% of Document Change Requests, Deviations, NCRs and CAPAs were initiated, reviewed & closed in less than 30 days.
• Reduced cost of Maintenance (over $65,000 in savings) by transferring PM & Calibration in-house for certain equipment.
• Reviewed label proofs for clinical trial products per cGMP and GCP.

• Managed the company's quality systems, procedures and policies.
• Managed GMP release of clinical products, released & completed kit inspections for Reagent Manufacturing. Released BioXp instruments.
• Reviewed instrument manufacturing production records.
• Managed Environmental Monitoring (EM) and cleaning programs of the GMP suite.
• Started/managed the internal and supplier audit programs.
• Hosted customer audits and Nemko Regulatory inspections.

San Diego, CA, US

• Managed the company's quality systems, procedures, and policies.
• Managed audit program (following cGMP & GCP) domestically and globally.
• Hosted over 70 clients, FDB and QP audits, provided and managed responses to audits. Over half of the hosted audits resulted in no observations.
• Improved number of audit observations from 4 to 1 per audit since Q4 2016.
• Supported various customers throughout Phases I, II and III of their studies with IVRS and GCP audits, drug reconciliation from clinical sites (blinded and open label studies) and documentation following GCP prior to.
• Created a Self-GMP Questionnaire in Q1. The Self-GMP Questionnaire saved the company 250 QA work hours and ~$25,000.

San Diego, California, US

• Quality Assurance Manager – CMC Operations
• Provided QA support for Halozyme’s partners Baxalta/Shire and their products.
• Completed protocol reviews, study reports, QC data package audits and performed external vendor audits.
• Completed ad hoc Regulatory Section audits and reviewed according to timeline requirements.
• Supported implementation and testing of Veeva Vault before going live.
• Reviewed Annual Product Reviews (APRs, APQRs) for Hylenex and HUA Drug Substance.

San Diego, CA, US

• Oversaw the company's quality systems, maintained procedures and policies.
• Approved controlled documents and ensured compliance with cGMP and GCP.
• Interacted with operations, project managers, and customers to address and resolve quality issues.
• Managed and maintained pest control, calibration, equipment and storage qualification and PM programs.
• Performed review/approval of batch records, pre- and post-execution and generated CofCs for customers.
• Reviewed/approved quality investigations, NCMRs, CAPAs, planned deviations and change requests.

San Diego, CA, US

• Initiated, monitored/trended change controls, CAPAs, and investigations (Deviations and OOS/OOT).
• Reviewed/approved batch records and supported disposition of drug substances.
• Performed line clearances and provided QA floor support for upstream/downstream clinical manufacturing.
• Reviewed/approved QC data & QC method qualifications (Analytical Chemistry and Microbiology assays).
• Reviewed/approved and created/revised SOPs. Maintained SOP binders.
• Reviewed/approved calibration records, IQs, OQs, PQs & performed internal audits.

• Improved the CAPA Quality System process from 38% closed on time to 100%.
• Supported Clinical QA Director with Clinical QA (CQA) SOPs.
• Improved Document Management System by providing list of open/pending DCRs.
• Improved employee training by introducing elements of tracking SOP training.
• Reviewed, approved environmental monitoring data, QC Data, MBRs and processed/oversaw DCRs.
• Participated in product risk management activity with manufacturing engineers and senior management.

Foster City, CA, US

• Determined sampling efficiencies by revising Microbiology SOPs.
• Communicated/informed the site about all environmental excursions and status of individual CAPAs.
• Ensured all investigations/CAPAs were completed timely and determined root cause analysis.
• Completed monthly and quarterly Environmental Monitoring Trend Reports
• Assisted Sr. Management with response to a Warning Letter from the FDA.
• Reviewed QC data and completed quality events for Ambisome commercial drug and Cayston Orphan drug batches.

US

Managed several activities within the Q.A. Lab such as routine Endotoxin (LAL) testing for medical devices, Bioburden testing; Environmental Monitoring testing, Heparin solution testing.Coordinated audit reports for Q.A. lab activities, completed monthly & annual lab reports, reviewedsterilization batch paperwork & approved release of sterilized.

M.S. In Biotechnology, Biotechnology - With A Concentration In Regulatory Affairs

Mba, Global Management

B.S., Microbiology

High School Diploma, Igcse And As Levels