Director of Quality GxP

Patrick Burke O’Meara

Clarksburg, MD ***** • 732-***-**** • *********@*******.***

QUALITY AND COMPLIANCE PROFESSIONAL

Proven leader with experience/ expertise in US and international regulations and guidelines related to GMP/GDP/GLP/GCP within the Pharma/Biotech/Medical/Device/ATMP/Tissue industries, from Phase II through 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:

• Internal/External Auditing

• Supply Chain Management

• Vendor Management

• Compliance/Inspection Readiness

• Quality Agreements

• KPI and Metrics

• Training (GMP/GxP)

• Quality Management Review

• Training

Dosage forms:

• Parenteral

• Tablets, Capsules and Liquids

• Topical

• Inhalation (MDI/DPI)

• Biologics

• Human Tissue

• Medical Devices and Combination Products

• ATMP’s

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, DigiSign, MS Teams, Skype, Zoom and One Vault. Extensive knowledge of FDA, EU, HPRA, ANVISA and Health Canada regulations as well as ICH, WHO, USP, EP, JP, cGMP, GLP, GDP and Federal Safety Regulations and equipment qualification, calibration, and validation.

EXPERIENCE

KUEHNE & NAGEL

Director Quality Assurance US Contract Logistics June 2023 – present Develop and maintain the contract logistics pharma & healthcare (PHC) quality management system (QMS), regarding GXP (i.e., GDP, GSP, GMP). Ensure compliance of individual QMS at different national/international warehouse locations according to all applicable regulatory, customer and company guidelines. Functional and disciplinary leadership of all Local Pharma & Healthcare Operations Quality Managers at the individual local sites.

• Implement and maintain a Regional Pharma & Healthcare Quality Management Systems within Contract Logistics business unit, in line and in compliance with Local, International as well as any KN Global applicable Guideline.

• Provide Pharma & Healthcare quality expertise and leadership to management, operational personnel, and clients.

• Support locations to Interact both internally with company personnel and externally with clients/ regulatory bodies/regulatory agencies.

• Create and implement Quality Inspection plans, manage quality process audits ensuring that self-inspections are performed at appropriate regular intervals and that areas for improvement are identified and addressed.

• Make sure process metrics are established, and in-line and end-of-line process controls to ensure quality objectives are met.

• Develop and Implement training programs, as required, to ensure quality objectives are met and to continually improve results.

• Develop and maintain interactions with client Quality counterparts; actively understand and manage client Quality expectations.

• Proactively communicate with client QA counterparts and management concerning quality issues, improvement plans, and status.

• Assure team members have and actively follow processes for review and disposition of non-conforming product including management of product damage, expiry, quarantine, holds, returned goods, and recalls, ensuring that all relevant data is documented and communicated to clients.

• Inform and prepare operational personnel regarding regulatory inspection readiness and act as the Point of Contact during inspections.

• Support interaction and discussion around execution of Quality Agreements with customers, and working with QSHE, Quality Agreements with relevant KN suppliers.

• Ensure operational and quality alignment with customer Quality Agreements.

• Represent company from a Quality perspective at client Quarterly Business Reviews.

• Manage six (6) direct reports supporting Quality/Regulatory functions. SEAGEN

Associate Director - Compliance Auditing Sep 2022 – June 2023 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 the planning and conducting of 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, effectiveness verification and closure.

• 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 required risk management activities are documented appropriately.

• Partner with External Supply Operations and Quality to assure supplier/vendor compliance.

• Partner with corporate, sites and affiliates to determine audit schedule and execute.

• 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.

• Provide support to 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.

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

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

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

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

• Act as internal quality/compliance consultant and provides resources with expertise.

• Assists in complaint investigations.

• Assure 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.

• Managed two (2) direct reports.

ABBVIE June 2019 – 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 ten (10) direct reports including personnel located at international locations and responsible for the administration of their job functions.

• Support the completion of special departmental 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. (acquired by ABBVIE) June 2015 – 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.

• Plan and conduct 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 conduct business critical audits as assigned by the head of Global Compliance department.

• Managed eight (8) direct reports.

FOREST RESEARCH INSTITUTE (acquired by ALLERGAN) July 2009 - September 2016 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.

• Manage quality compliance projects and perform risk- based approach to scheduling, executing, and following upon CAPA for internal and external audits.

• Schedule 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.

• Act as SME and provide support to sites during inspections and customer audits.

• Managed direct four (4) direct reports.

FOREST RESEARCH INSTITUTE March 2006 – July 2009

Senior Compliance Specialist

Evaluated, Scheduled and Conducted internal cGMP audits of Forest manufacturing, testing, and packaging sites to ensure compliance with FDA regulations, Ministry of Health requirements, cGMP's, Quality Agreements and SOPs.

• Perform routine, due diligence and for cause audits of internal facilities and suppliers.

• Track CAPA and effectiveness to closure and provide metrics to management.

• Establish Quality Agreements with internal and external partners. EDUCATION

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

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

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