Pat Mcnally's Location
Phoenixville, Pennsylvania, United States, United States
Pat Mcnally's Contact Details
Pat Mcnally work email
- Valid
- Valid
- Valid
Pat Mcnally personal email
n/a
Pat Mcnally phone numbers
About Pat Mcnally
Over 30 years of experience in the pharmaceutical industry including Regulatory Compliance, Quality Assurance and Operations.
Pat Mcnally's Current Company Details
Senior Quality Professional
Pat Mcnally Work Experience Details
-
Head Of Quality, Cell And Gene TherapyCatalent Pharma Solutions Jun 2024 - Nov 2024Somerset, Nj, UsResponsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to assure the site is compliant with regulatory, Corporate, and customer requirements. Responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. Responsible for Quality Assurance, Quality Validation Oversight, Quality Systems and Quality Control. Responsible person for batch disposition. Responsible to provide project guidance and support and work with customers to resolve quality concerns, as appropriate.Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan, Quality Unit objectives and related procedures. -
Senior Director, Quality, Drug Product Division – North AmericaThermo Fisher Scientific Nov 2021 - Apr 2024Waltham, Ma, UsResponsible for Quality Assurance, Quality Control and Regulatory Compliance at Toronto, CA, Whitby, CA, Cincinnati, OH, Greenville, NC, High Point, NC, Manati, PR and Bend, OR sites. -
Sr. Director, QualityThermo Fisher Scientific Sep 2018 - Nov 2021Waltham, Ma, UsManage and direct the activities of the Quality Assurance, Quality Compliance, Quality Support, Quality Control, Microbiology departments as well as Training. Responsible for Greenville, NC, High Point, NC, and Tilburg, NE sites.
-
PresidentPadraig Consulting Llc Jan 2006 - Nov 2021Services Provided• Computer Systems Selection, Deployment, Audit and Validation• Quality System Design, Deployment, Management, Training And Improvement• Standard Operating Procedure Development• Process and Cleaning Validation Protocol and Report Preparation• Quality Assurance and Regulatory Compliance Audit• Regulatory Submission Preparation, Regulatory Agency LiaisonSelected Consulting Projects• Contract Auditor (June 2012 – Dec 2014) – Shire Human Gene Therapies, Lexington, MA. Responsible for conducting program audits of existing and potential suppliers of computerized clinical data management systems and services such as Interactive Voice/Web Response Systems, Clinical Trial Management Systems, and Data Management. Audits include review of the overall Quality Management System, Computer System Validation and Data Center Management. • Contract Auditor (October – December 2009) – sanofi aventis, Bridgewater, NJ. Responsible for conducting program audits of existing and potential suppliers of computerized clinical data management systems and services such as Interactive Voice/Web Response Systems, Clinical Trial Management Systems, and Data Management. Audits include review of the overall Quality Management System, Computer System Validation and Data Center Management.• Quality System Auditor (May – July 2008) – CSL Behring, King of Prussia, PA. Responsible for conducting a comprehensive Quality Management System Audit with respect to the overall control and management of the migration of SAP 4.7 to SAP ECC6 from a GxP perspective. Reviewed all validation project deliverables for compliance with organizational standard operating procedures, regulatory compliance, and industry standards.
-
Site Quality DirectorMallinckrodt Pharmaceuticals Feb 2015 - Sep 2018Dublin, Ireland, IeResponsibilities• All Quality Assurance, Quality Control, Quality Systems, Regulatory Affairs, Regulatory Compliance and Validation activities at the site including 80 to 95 total direct and indirect reports. • As a member of the site Senior Leadership Team (SLT), responsible for championing key strategic initiatives such as Continuous Improvement, Quality Culture and Incident Reduction.• New York State Board of Pharmacy Site Supervisor (Controlled Substances Compliance)Key Accomplishments• Led one Health Canada and three FDA inspections with no significant observations. The April 2018 FDA inspection concluded with no FD483 observations. • Managed seven client audits with no significant observations. • Four Abbreviated New Drug Application (ANDA) and over 30 Supplement approvals.• Achieved significant organizational improvement through deployment of Quality Operational Excellence Hoshin Kanri A3 project plans. Highlights include:o 20% improvement in First Time Right (FTR) through 2016 and sustained through 2018.o 65% reduction in errors attributable to Human Factors.o 60% reduction in error rate.o 11% Quality Culture Index improvement from 2016 to 2017 as determined by the CEB Quality Culture Diagnostic. Continuing to champion Quality Culture improvement through 2018 – focusing on Quality Ownership, Messaging and Leadership.• Completed realignment of the entire organization to achieve 20% reduction in overall headcount without compromising service or quality.• Effectively managed costs to achieve budget favorable by 10% for 2016 and 17% for 2017. .• Established Key Performance Indicators (KPIs) and tracked for improvement in all functional areas including Safety, Quality, Service, and Cost. 90% achieving or exceeding at 2016 year end. -
Director, Quality Assurance And ComplianceQs Pharma Mar 2014 - Feb 2015Responsibilities• Oversight of all Quality Assurance and Compliance activities at QS Pharma. Ensure company adherence to Good Manufacturing Practices (GMPs), applicable regulatory standards, and internal procedures and practices.• Quality Management and Training Systems. • Development and implementation of compliance standards and procedures in conformance with GMP, ICH, and other regulatory requirements.• Regulatory control and inspectional activities including preparation, coordination, hosting and follow-up to ensure that all required corrective and preventative actions are completed.• Internal and external audit program including development and approval of Quality Assurance Agreements and/or Technical Agreements.• Documentation Control, Annual Product Review, Complaints and Adverse Drug Experience Reporting, Regulatory Licensing and Certification, CAPA, Change Controls, and Batch Record Release systems.Key Achievements• Reset and optimization of the site Learning Management System (LMS).• Expansion of the internal audit program and certification of 12 additional internal auditors.• 22 client audits hosted without significant observation.• Establishment of expanded cGMP training program including annual recertification and weekly face-to-face topic delivery.
-
PresidentAlliance Contract Pharma, Llc Mar 2008 - Sep 2013Responsibilities• Overall management and performance of the company. Alliance Contract Pharma is a full service contract manufacturing and laboratory services organization supporting the pharmaceutical and dietary supplement industries.Key Achievements• Successfully funded, incorporated, registered and launched the company. • Achieved operational state in less than one year.
-
Director, OperationsElan Mar 2006 - Oct 2007Dublin 2, IeResponsibilities• Plan, establish and oversee major goals and initiatives of the Operations sub-function at the site which included Analytical Sciences, Clinical Supply Manufacturing, Facilities, GMP Operations and IT (58 total direct and indirect).• Manage GxP computer systems including SOP management system (Documentum), materials management (Access), and laboratory data acquisition and management.• Responsible for Profit and Loss (P&L) for each function.• Actively participated in regulatory, corporate and client audits of the KOP site.Key Accomplishments• Led a change and improvement in the productivity, efficiency and compliance culture of the Operations group. • Retooled the organization and instilled a sense of cooperation to remove the barriers between the Quality and Operations teams - recent audit confirmed compliance status which was previously questionable. • Workplan development, tracking and execution were improved dramatically - integrated project plans now match client invoicing. • The approach to environmental health and safety was been reviewed and improved. • A rationale approach to budget management was implemented to ensure that expenses are planned and managed efficiently - 2007 overall budget tracking >20% favorably. -
Director, Quality ManagementPmrs Nov 1994 - Feb 2006Horsham, Pa, UsResponsibilities• Overall performance of the company. • Responsible for development, implementation and management of all quality systems to ensure compliance to customer, quality assurance and regulatory requirements. Key Accomplishments• During tenure as a director of the company, PMRS achieved an average annual revenue growth rate of 20% and an average annual net income of 36%.• Directed the pre-approval compliance effort leading to the FDA approval of 10 commercial products. Also, received MHRA approval for the manufacture and control of two commercial products for the European Union.• Managed 12 FDA and EMA inspections ensuring efficient management of observations, corrective action commitment and completion.• Identified, sourced and led the deployment and validation of various GMP computer systems such as document management (CyberLab), Materials Management (DMI/CS), Investigation and CAPA Tracking (Trackwise), LIMS (in-house developed), and Label Generation (Easy Label). • Led the corporation in the development of a world class quality management system including certification to ISO9001-2004. -
Manager, Vendor QualityOhmeda, Ppd 1994 - 1994Responsibilities• Consumer complaint system improvement and management. • External auditing and reporting vendor quality performance.Key Accomplishments• Developed an electronic database for customer complaint logging, tracking and reporting.
-
Associate Director, Product QualityGreenwich Pharmaceuticals, Inc 1992 - 1994Responsibilities• All quality assurance functions for all pre-clinical, clinical, and commercial manufacturing operations. • Regulatory Compliance• Raw material, intermediate and finished product release. Key Accomplishments• Developed and deployed all necessary GMP quality systems for the start-up organization.• Lead efforts to prepare for and successfully complete an FDA Pre-Approval Inspection.
-
Quality Systems SpecialistRhone-Poulenc Rorer 1988 - 1992Responsibilities• Establishment and maintenance of all standard operating procedures (SOPs) utilized by the site. • Internal and external GMP audit.• GMP training and quality performance tracking and reporting.Key Accomplishments• Completely reformatted and organized the entire SOP system. Organized SOPs in rational systems and established operational owners for each. -
Consumer Safety OfficerFda 1987 - 1987Silver Spring, Md, UsResponsibilities• Inspections of food and drug manufacturers, shippers and warehousers to determine compliance to the Food, Drug and Cosmetic Act.
Pat Mcnally Skills
Gmp
Fda
Pharmaceutical Industry
Quality Assurance
Validation
Quality System
Capa
21 Cfr Part 11
Gxp
Computer System Validation
Pharmaceutics
Change Control
Quality Management
Sop
Technology Transfer
Cro
Operations Management
Medical Devices
Biopharmaceuticals
Formulation
Biotechnology
Manufacturing
Standard Operating Procedure
Regulatory Affairs
Continuous Improvement
Contract Manufacturing
Regulatory Requirements
Laboratory
U.s. Food And Drug Administration
Glp
V&v
Drug Development
Corrective And Preventive Action
Cleaning Validation
Clinical Development
Gcp
Regulatory Submissions
Ctms
Pat Mcnally Education Details
-
Temple UniversityOperations Management -
Rutgers University - CamdenBiology
Frequently Asked Questions about Pat Mcnally
What is Pat Mcnally's role at the current company?
Pat Mcnally's current role is Senior Quality Professional.
What is Pat Mcnally's email address?
Pat Mcnally's email address is pa****@****odt.com
What is Pat Mcnally's direct phone number?
Pat Mcnally's direct phone number is +121525*****
What schools did Pat Mcnally attend?
Pat Mcnally attended Temple University, Rutgers University - Camden.
What are some of Pat Mcnally's interests?
Pat Mcnally has interest in Poverty Alleviation, Science And Technology, Children, Environment.
What skills is Pat Mcnally known for?
Pat Mcnally has skills like Gmp, Fda, Pharmaceutical Industry, Quality Assurance, Validation, Quality System, Capa, 21 Cfr Part 11, Gxp, Computer System Validation, Pharmaceutics, Change Control.
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial