Rooney Oldham Email & Phone Number

Director, Quality Assurance GMP (USA) @ InflaRx N.V.

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Rooney Oldham Location

Reeds Spring, MO, US

Rooney Oldham Work

Director, Quality Assurance GMP (USA) @ (October 2024 - Present)
Director Of Quality Control and Analytical Development @ (April 2022 - July 2024)
Director Of Quality @ (August 2021 - April 2022)
Director, Quality and Regulatory Affairs @ (January 2018 - June 2021)
Sr. Director API Quality Operations, US and India @ (January 2016 - January 2018)
Director Quality Control @ (January 2015 - January 2016)
Director of Analytical Services @ (January 2011 - January 2014)
Manager, Quality Control Development @ (January 2009 - January 2011)
Director, Analytical Chem and Quality Control @ Acceleration (January 2003 - January 2009)

Rooney Oldham Education

Rockhurst University
BS (Biology / Chemist)

Rooney Oldham Skills

High-Performance Liquid Chromatography (HPLC)
Stability Studies
Analytical Techniques
Communication
Quality Metrics
Technical Reviews
New Drug Application (NDA)
Regulatory Agencies
Contract Negotiation
Business Relationship Management
Request for Proposal (RFP)
Due Diligence
International Travel
Third Party Vendors
Problem Solving
GxP
FDA
GMP
Pharmaceutical Industry
Chromatography
Validation
Analytical Chemistry
Technology Transfer
Regulatory Affairs
Quality Control
Sop
Change Control
CAPA
Drug Development
21 CFR Part 11
Quality System
Pharmaceutics
Clinical Development
Drug Discovery
Pharmaceutical Development
Research and Development (R&D)
Quality Assurance
Good Manufacturing Practice (GMP)
Corrective and Preventive Action (CAPA)
Good Laboratory Practice (GLP)
Laboratory Information Management System (LIMS)
Management
Leadership
Cross-functional Team Leadership
Pharmaceuticals
Cleaning Validation
IND
CMC
USP
Process Improvement
Attention to Detail
Build Strong Relationships
Business Continuity
Business Process
Business Process Improvement
Business Units
Business Writing
CFR
Coaching & Mentoring
Compliance Management
Conflict Resolution
Contamination Control
Controlled Environments
Coordination Skills
Critical Thinking
Data Retention
Diverse Groups
Documentation Practices
E2E
EMA
EP
Federal Regulations
ICH
Industry standards
Internal Audits
Key Performance Indicators
Lean Principles
MHRA
Mergers & Acquisitions (M&A)
Microbiology
OOS
Operational Excellence
Parenteral
Policy Development
Pre-clinical Studies
Project Management
Quality Management
Quality Processes
Quality Risk Management
Raw Materials
Readiness
Regulatory Audits
Regulatory Examinations
Site Inspections
Strategic Planning
Succession Planning
Team Motivation
Third-Party Vendor Management
Timelines
Training
Written Communication

Rooney Oldham Summary

Rooney Oldham, based in Reeds Spring, MO, US, is currently a Director, Quality Assurance GMP (USA) at InflaRx. Rooney Oldham brings experience from previous roles at SCA Pharma, Piramal Pharma Solutions and AMRI (Albany Molecular Research Inc.). Rooney Oldham holds a BS in Biology / Chemist @ Rockhurst University. With a robust skill set that includes High-Performance Liquid Chromatography (HPLC), Stability Studies, Analytical Techniques, Communication, Quality Metrics and more. Rooney Oldham has 3 emails and 2 mobile phone numbers on RocketReach.