Patrick Burke O’Meara

Clarksburg, MD ***** • 732-***-**** • adylwx@r.postjobfree.com

QUALITY AND COMPLIANCE PROFESSIONAL

Proven leader with extensive experience/ expertise in US and international regulations and guidelines related to GMP/GDP/GLP/GCP within the Pharma/Biotech/Medical Device industries, from Phase II through the Commercialization and post-marketing evaluation. Results-oriented individual with extensive customer service experience and strong verbal and written communication skills. Proven ability to interact with all departments and individuals to ensure the production of quality materials (specifically finished drug substance and finished Drug product) and the ability to meet goals and deadlines. Core competencies include: Risk Management • Supply Chain • Global Audit • Internal Audit • Vendor Management • Quality Agreements • Compliance Readiness • Supplier Agreements • KPI and Metrics • QMR

Dosage forms: Parenterals, Oral (Tablets, Capsule & Liquids), Topical, Inhalation (MDI/ DPI), Biologics, Suppository, Medical Devices and Combination Products SKILLS

Proficient in Microsoft Word, Excel, Project, PowerPoint, Visio, LIMS, Lotus and all IBM/ Macintosh compatible software. Proficient in Trackwise, Veeva as well as SAP operating systems, DocuSign and One Vault. Extensive knowledge of FDA, EU, HPRA, ANVISA regulations, Q7, ICH, WHO, USP, EP, JP, ICH, cGMP, GLP, Federal Safety Regulations and equipment qualification, calibration and validation. EXPERIENCE

Seagen

Associate Director - Compliance Auditing Sep 2022 - present Provide comprehensive and advanced knowledge of auditing principles. Execute highly complex or specialized audits supporting global manufacturing, testing, and distribution of clinical and commercial products.

• Responsible for planning and conducting complex Good Manufacturing Practice/Good Distribution Practice (GMP/GDP) quality audits supporting clinical and commercial programs.

• Manage all aspects of the audit lifecycle: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CAPA, and closing

• Provide tactical direction of the auditing function, including Direct Materials, Contract Manufacturers, Contract Laboratories, Software and support functions: responsible for monitoring vendor compliance with the requirements of cGMPs and applicable regulations, perform audits of external suppliers and/or interface with internal manufacturing site Quality team as applicable.

• Ensure vendor risks are systematically assessed, controlled, reviewed, and communicated, and that risk management activities are documented appropriately.

• Partner with External Supply Operations to audit suppliers for Seagen.

• Partner with Corporate, site and affiliates for internal audit schedule and execution.

• Participate in Due Diligence activities for assessment and selection of CMOs, partners, acquisitions, etc.

• Involved in developing, modifying and executing company policies that affect immediate operations(s) and may also have regional or entity/companywide effect

• Work with Management to establish operational objectives and assignments

• Provide tactical direction to ensure auditing function drives compliance and continuous improvement of the Corporate, site, and country affiliate systems, processes, and operational performance.

• Provide departmental leadership regarding establishment of corrective actions in response to audit findings.

• Support generation of audit metrics - Ensure metric output is used to further develop and strengthen compliance programs.

• Provide leadership and coaching to Quality Compliance audit team

• Identify process improvements in the Quality Compliance department to ensure programs remain compliant with internal procedures and federal and local requirements for Seagen markets.

• Lead and participate in risk assessment, investigation activities, and decision-making for compliance programs.

• Review and approve relevant Compliance documentation and ensure documentation supports a compliant state.

• May have responsibilities within the auditor training and qualification process Kite Pharma Aug 2021 to Sep 2022

Site Compliance Lead – Compliance

Directed the site internal audit program to verify compliance with global Good Manufacturing Practices regulations, and corporate requirements. Ensured appropriate corrective and preventative actions are taken when required. Assures tracking of corrective action commitments to completion and follow-up to assure sustained, effective implementation. Responsible to lead the preparation, management of external audits and inspections. Worked directly with regulatory investigators.

• Hosted internal corporate and external agency inspections. Work with Quality and Site Leadership to ensure the site is inspection ready with no lead time.

• Reviewed documents and provides input, coaching and feedback to promote continuous improvement.

• Assures communication of compliance concerns, regulatory agency inspections and industry trends as part of on-going education and training for GMP compliance.

• Worked closely with functional areas (i.e. Manufacturing, QC, etc.) to ensure GMP compliance.

• Acts as internal consultant and provides resources with expertise. Assists in compliant investigations.

• Assures tracking of key performance metrics and provides input to periodic reviews of effectiveness of the Quality Management System.

• Develop and execute QA objectives to align with business plan goals and improvement initiatives.

• Participate in developing global policies and procedures. Establish a process to ensure functional site procedures are in compliance with global policies. ABBVIE June 2019 to May 2021

Associate Director – Strategic Planning & Operations Compliance Lead a team of auditors responsible for the planning and execution of all the external audits such as Contract Manufacturers, API Suppliers, Excipient Suppliers, Primary and secondary packaging components, printed materials, warehouses, around the globe.

• Planned and conducted internal audits of manufacturing, packaging, and testing supporting clinical and commercial pharmaceutical, biologics, medical device, and combination products.

• Created external audit program and executing with appropriate procedures and reports in compliance with changing global regulatory requirements.

• Managed direct reports (10) including personnel located at international locations and responsible for the administration of their job functions.

• Support the completion of special projects/goals and tasks as assigned.

• Assist in the Supplier and Material Management program related to the scoring and quality/ compliance oversight of material and service providers. ALLERGAN, PLC. September 2015 to May 2019

Associate Director – Compliance

Lead a team of 8 US and International based auditors responsible for the planning and execution of all the external audits such as Contract Manufacturers, API Suppliers, Excipient Suppliers, Primary and secondary packaging components, printed materials, suppliers, warehouses, around the globe.

• Planned and conducted internal audits of manufacturing, packaging, and testing facilities supporting

clinical and commercial pharmaceutical, biologics, medical device and combination products.

• Created external audit program compliance with changing global regulatory requirements and con- duct some key audits as assigned by the head of Global Compliance department.

• Managed direct reports (8).

FOREST RESEARCH INSTITUTE July 2009 - September 2015 Compliance Manager

Executed and administered an internal system audit program within commercial and late- stage development functions that identify compliance issues and remediation activities to resolve issues.

• Managed quality compliance projects and perform risk- based approach to scheduling, executing,

and following up CAPA for internal and external suppliers.

• Scheduled audits of internal sites as well as external vendors to assure resource are used effectively while also ensuring compliance with FDA regulations, cGMP’s, and SOP’s. FOREST RESEARCH INSTITUTE March 2006 - July 2009

Senior Compliance Specialist

Evaluated, Scheduled and Conducted internal cGMP audits of Forest manufacturing and packaging sites to ensure compliance with FDA regulations, cGMP's, and SOPs. EDUCATION

Bachelor of Arts: English Literature - Mount Saint Mary’s College Bachelor of Science: Biology - Mount Saint Mary’s College DEVELOPMENT

cGMP/cGLP Refresher Training (Pharmaceutical Training Seminars) GMP Compliance Training for Schering Corporation (Pharmaceutical Compliance Associates hosted by Mr. John Y. Lee)

Auditing Internal/External Techniques (Global Pharma Consulting hosted by Michael Anisfeld) Quality Management of Contractors and Interpretation of EU Guide on GMP (David Begg Associates) cGMP Training Seminar for the Biotechnology and Pharmaceutical Industries (SPI USA in association with the University of Maryland Baltimore County) Best Practices for Auditing GMP Documents and Records (Teleconference led by FDA News) Microbiological Control and Validation – (Seminar led by The Center for Professional Advancement) PDA/FDA Joint Regulatory Conference ISPE – Process Validation in Biotechnology and Pharmaceutical Manufacturing PDA/FDA Joint Regulatory Conference

Aseptic Processing Training

PDA/FDA Joint Regulatory Conference

2011 PDA/FDA Joint Regulatory

Conference

ISPE – Process Validation in Pharmaceutical

Manufacturing ISPE – Pharmaceutical GMP

Manufacturing Conference

Global Harmonization Practices: Overweight/Underweight Tablets Conducting Effective Quality Audits: Beyond Audit Checklists

ISO 13485:2016 Updated Guideline

Training Combination Product

Compliance – Chimera GMP for

Biological an Biotechnology Products ISO

13485/MDSAP Certification

Supplier Quality Workshop Xavier Health of Xavier University Annex 1 PDA Conference

MEMBERSHIPS

Parental Drug Association (PDA) • International Society for Pharmaceutical Engineering (ISPE)

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