Angela Calkins HUMRICH
Lafayette Hill,PA
Summary
› OVER TWO DECADES OF EXCELLENCE IN BUILDING FORWARD-THINKING QUALITY, REGULATORY, AND COMPLIANCE (QRC) ORGANIZATIONS which actively enables growth and safeguards against emerging areas of risk. Experience building sustainable corporate-wide Quality Management systems and creating a “right first time” culture.
› A COLLABORATIVE AND TRANSPARENT LEADER with a passion for realizing the untapped potential of our people and operations. Unafraid to forge consensus in conflict-ridden situations and capitalize on the “quick-win” on the road to deeper transformation. The ability to effectively build and maintain relationships across the organization to effectively solve problems.
Overview
21
21
years of professional experience
Work History
US Head of Quality
Uniphar Group
Garner, NC
02.2024 - Current
- Advised senior executives on approaches for resolving complex issues impacting operations
- Identified problems and implemented solutions to better streamline operations
- Communicated regularly with executive team members to deliver pertinent details related to progress status and direction for projects
- Conducted risk assessments to identify potential areas of non-compliance with regulatory requirements
- Collaborated with cross-functional teams to ensure that all processes are compliant with relevant regulations
Vice President of Quality & Regulatory Affairs
Eurofins
Horsham, PA
08.2022 - 02.2024
- Reviewed blueprints, drawings and other specifications to fully understand project expectations
- Worked alongside developers and other project stakeholders to build out new GxP clinical packaging and labeling facility
- Augmented knowledge of ERP software and tools by actively participating in available trainings and workshops
- Implemented new ERP system to drive quality, consistency, and compliance within Operations
- Explored new technologies and tools for productivity, security and quality assurance purposes
US Head of Quality & Regulatory Affairs
Clinigen Clinical Supplies Management Inc
Fargo, ND
02.2003 - 08.2022
- Established a robust Quality, Compliance and Risk Management organization driving 25%+YOY reductions in deviations and non-conformances, major improvements in data-driven decision making and attaining KPIs, and a truly forward-thinking approach towards addressing emerging areas of risk
- Served as a trusted partner to senior leadership in defining long-term strategy
- Provided Quality oversight to 4 facilities
- Designed and led the internal audit and inspection readiness program resulting in 6 successful regulatory inspections and 125 successful client audits over 2 years
- Forged strong working relationships with federal and state regulators and demonstrated a talent for moving past complex roadblocks
- Redefined the role of Quality as a key facilitator of overall growth
- Maintained full compliance with the FDA, ICH, DEA, NABP, USDA import/export permits, GxP regulatory standards, and state licensing requirements during a period of spiking customer demands
- Implemented global Quality Governance Meetings with client Quality to ensure all entities involved are on the same page
- Maintained full compliance with states ensuring the appropriate licenses were acquired for clinical trials and Direct-to-Patient activities
- Experienced with requirements of the USDA for importing from Ex-US countries
- Defined core quality goals and partnered with global Quality Directors on strategy-through-execution of major initiatives
- Led, mentored, and supported the need of Quality Assurance and Quality Systems team members
- Emphasized priorities which yield both ROI and enable Clinigen to become a fundamentally stronger and more sound organization for years to come
- Brought an entirely new level of data-driven decision-making into play through implementation of an electronic Quality Management System (eQMS) standardizing and harmonizing quality metrics, KPIs, and reporting across the entire company
- Created a quality compliance scorecard, and numerous assessment reporting tools for accurately gauging the effectiveness and inspection readiness of quality management systems
- Ensures alignment of global compliance activities to business activities with a focus on Growth, Innovation, and Operational Effectiveness across all functional areas
- Changed the Quality and Compliance organization’s role from “putting out fires” into an active enabler of sustainable growth, including assessing internal and external areas of vulnerability
- Introduced a virtual audit platform with no paper for hosting onsite audits which enabled the transition for complete virtual audits during COVID
- Implemented a global Learning Management System and training program.
Education
Bachelor of Science, B.S - Biochemistry & Biotechnology
Minnesota State University Moorhead
Moorhead, MN05.2018
Masters of Proficiency - Science
Minnesota State University
01.2009
Associate of Science - Pharmacy Technician
North Dakota State College of Science
Wahpeton, ND01.2005
Some College (No Degree) - Mechanical Engineering
Wharton County Junior College
Wharton, TXSkills
- GxP, GDP
- CAPA
- Lean Six Sigma Green Belt
- Validation
- Regulatory Compliance
- SOP Development
- Change Control
- QMS Auditing
- Resource Allocation
- Process Improvement
- Budget Oversight
- Complex Problem-Solving
- Change and Growth Management
- Relationship and Team Building
- Leadership and People Development
- Integrity and Transparency
Timeline
US Head of Quality
Uniphar Group
02.2024 - Current
Vice President of Quality & Regulatory Affairs
Eurofins
08.2022 - 02.2024
US Head of Quality & Regulatory Affairs
Clinigen Clinical Supplies Management Inc
02.2003 - 08.2022
Bachelor of Science, B.S - Biochemistry & Biotechnology
Minnesota State University Moorhead
Masters of Proficiency - Science
Minnesota State University
Associate of Science - Pharmacy Technician
North Dakota State College of Science
Some College (No Degree) - Mechanical Engineering
Wharton County Junior College
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