Apex Compliance Solutions

As CEO of Apex Compliance Solutions, I am dedicated to driving strategic vision, fostering innovation, and cultivating a culture of excellence within our organization. With a focus on delivering unparalleled value to our clients and stakeholders, I lead our talented team in achieving ambitious goals and propelling the company forward. Through effective leadership, collaboration, and a relentless commitment to quality, we are shaping the future of compliance solutions and empowering businesses to thrive in a dynamic regulatory landscape.

Chief Executive Officer

University of Vermont Grossman School of Business

As a member of the advisory board for Women in Leadership Program at Grossman School of Business I have the opportunity to evaluate coursework and advocate for women in different organizations.

Advisor

Vernal Biosciences

Responsible for building and qualifying early phase to commercial quality and operations. Recruit a high-performing team capable of manufacturing and testing high-quality LNP-mRNA for third-party clients.

Senior Vice President, GMP Operations

Recruit talented individuals for Quality Control, Validation, and Quality Systems and continue to build a quality culture focused on collaboration and transparency. 
Implement cloud based quality management system with a focus on risk-based quality to support phase appropriate guidelines for GMP manufacturing.

Senior Vice President of Quality 

ETI Capital

Works to ensure a robust leadership culture exists; aligning strategic goals with leadership behaviors. Providing a unified approach for the consistency of company culture, among them corporate purpose and values and the equity and inclusion strategy. Provides training and coaching on the fundamental basics of valued leadership traits from executive team to individual contributors.

Board Member

1st Detachment Nutrition

Work closely with the CEO to develop strategy for the company, not limited to the company's mission, vision, and culture. Has a deep understanding of the business to optimize and expand target market segments of the nutritional industry. Along with a strong background in leadership and quality, is also able to assist in product development and marketing.

Board member 

Vibalogics

Built a talented Quality team of over 22 individuals in the span of 1 year, including Quality Assurance, Quality Management Systems, and Quality Control. Installed a cloud based quality management system and prepared the site for GMP manufacturing. Implemented strategies to accomplish the company's quality and compliance goals and partnering with key stakeholders to meet regulatory expectations and requirements for phase appropriate manufacturing as a CDMO.

Vice President Of Quality

Emergent BioSolutions

Provided Quality oversight and direction for the Bayview quality compliance and quality operations functions to ensure patient safety and compliance with FDA and other applicable health authority requirements. Provided strategic planning for continuous improvement and reporting/escalation of quality issues and risk mitigation activities. Ensured a culture of quality and compliance through effective leadership and strict adherence to Emergent's core values.

Director Of Quality Assurance

Merck

Lead Quality team in support of culture media, black widow spider antivenin and weigh & dispense operations ▪ Collaborate with technology operations on process improvements including single use mixers and third party manufacturing of media and buffers ▪ Approver of investigations and deviations .

Associate Director, IPT Quality Lead

Responsible for the management, training & development of incoming materials quality specialists ▪ Collaborate with shipping, receiving and logistics to support multiple products site wide ▪ Approver of investigations and change control

Interim IPT Quality Lead, Incoming Materials

Responsible for the management and training of quality operations support staff to sterile
supply ▪ Collaborate with technology and operations for continuous improvement activities
involving safety and compliance ▪Lead Sterile Supply in internal and external regulatory audits

Interim IPT Quality Lead, Sterile Supply

Train and oversee support staff of 100 within Operations and Quality Associates on regulatory compliance ▪ Collaborate with Operations and Technology Operations in improving current and new processes ▪ Perform quality audits for site supply of sterile processing equipment ▪ Review SOP’s, Change Control Reports, Corrective and Preventative Actions, Continuing Validation Protocols and Final Reports

Senior Specialist, Quality Operations

Independently worked on capital projects, change requests, and deviation investigations ▪ Managed product transfers, technology transfer, and implementation of single use mixing technology ▪ Led closeout of major critical investigations with product impact ▪ Met critical timelines as part of collaboration with Manufacturing Operations and Laboratory Testing ▪ Supported manufacture of Culture Media used in downstream vaccine franchises

Tech Services Specialist/ Engineer

Leading Apex Compliance Solutions with a strategic vision, my tenure as CEO is marked by spearheading innovative practices and fostering a culture committed to excellence. Our focus on delivering top-tier compliance solutions is propelled by quality assurance expertise, ensuring our clients navigate the dynamic regulatory landscape successfully.

Previously, as SVP at Vernal Biosciences, my leadership was instrumental in establishing robust GMP operations and assembling a high-caliber team. The collaboration and quality-driven mindset we cultivated are the cornerstones of my mission to empower businesses and advance industry standards in compliance.

Judith Adair McCorry

The FI Woman, LLC 

Founder & CEO

Certified Personal Finance Counselor 

Investment Advisor Representative 

Tinu Publishing, LLC

Available on Amazon and other bookstores

* Fifty Shades of Green: A Stock Market Guide (2015)

* Kids & Money: The 5 Stacks Method (2021)

* Transform Your Finances: 28 Days to Financial Wellness (2022)

* One Year After F.I.R.E.: Stories and Lessons Learned in Early Retirement (2022)

Author

LEAD Scholarship Foundation, Inc.

Executive Board Member

CRC Industries

* Responsible for QA, QC, Lab operations, ISO 9001 Management, and Supplier Quality Management

* Coach internal Auditors and grow continuous improvement skills within CRC Americas 

* Drive employee engagement and act as a change champion for key initiatives in close partnership with all lines of business in CRC Americas.

* Fiduciary responsibility as a member of the 401(k) plan committee; participated in regular meetings with plan investment advisory firm and plan provider to:

 - Ensure plan compliance with all regulations.

 - Ensure best practices and transparency for the plan, for example, developing an investment policy.

 - Ensure continued benefits and adequate service levels for plan participants.

 - Review changes to Investing environment including investor behavior, government policies and investment class performance.

 - Cost and risk review for the plan assets.

Director, Quality

Associate Director, Quality

* Lead and participate in audits; applying GMP, GLP and GDP knowledge and experience to confirm adherence to regulatory requirements and uncover nonconformance or compliance risks.

* Provide Senior Management with analysis of compliance risks and drive mitigation actions.
 
* Manage the site shop floor inspection program to ensure compliance with the QMS

* Develop and implement a new Inspection Readiness program for a large vaccines manufacturing, testing and packaging site.

* Provide coaching, guidance and support to 60+ shopfloor auditors.

* Analyze and trend audit data and drive continuous improvement opportunities

* Collaborate with the various functions (operations, labs, engineering) to develop effective CAPAs

* Support and participate in Regulatory Agency inspections

* Review and approve corrective actions/CAPAs/SOPs to ensure effectiveness

Associate Director, Quality Assurance

* Provided Lean Six Sigma expertise in the design phase (FEL 1-3) of capital projects. 

* Developed and implemented a comprehensive Lean Six Sigma training program for a cross-functional technical group.

* Fostered continuous improvement by collaborating with project managers, estimators, architects, process engineers and senior management to create meaningful project KPIs, improve project execution and delivery and reduce cost.

* Drove the Knowledge Management process by facilitating After Action Review (AAR) sessions to capture and share “Lessons Learned” with other projects across the site.

Lean Six Sigma SME, Global Engineering 

* Managed a complex network of global and cross-functional teams to support the Januvia and Janumet end-to-end supply chain.

* Managed registration filings, labeling and packaging activities for new product images in different countries.

* Partnered with CMC and Regulatory Affairs to ensure compliance with country Health Authority requirements

* Performed data analysis and facilitated the execution of strategic plans for 6 global sites, including contract manufacturing sites.

* Proactively monitored supply chain KPIs for negative trends and facilitated the implementation of strategies to minimize potential impact.

Competencies:
* Lead large cross-functional, multi site projects
* Effective communication skills
* Project Management
* Advanced analytical skills

Sr. Product Analyst, Global Supply Chain Management

* Worked with site leaders to develop strategic goals, identify measurable objectives,  and develop Value Stream Maps

* Performed advanced statistical analysis and developed control charts that helped leaders drive appropriate action.

* Led Yellow Belt classes and contributed to curriculum development in the areas of 5S, 5-whys, 7 wastes, SIPOC, VOC, cause-analysis and prioritization, Kaizen, Takt time, Standardized Work and A3 reporting.

Competencies:
* Project Management (Led site-wide improvement projects)
* Change Management & Change Agent (Led Lean Transformation in key business areas)
* Problem solving coach
* Kaizen Facilitator
* Lean coach
* Yellow Belt trainer
* Green Belt mentor

Lean Six Sigma Analyst, Vaccines Manufacturing

* Managed a team of operators in vaccines manufacturing. 

* Directed daily work activities, coordinated the schedule and ensured adherence to quality standards.

* Identified and managed continuous improvement projects.

Sr. Manufacturing Supervisor, Vaccines Manufacturing

* Identified and led various continuous improvement projects in the vaccines inspection department.

* Provided troubleshooting expertise for the visual inspection machine.

* Performed Deviation Management investigations.

Manufacturing Engineer, Vaccines Manufacturing

Edward Jones

Financial Advisor

Procter & Gamble

* Managed 2 production lines
* Managed 16 technicians; responsible for helping them meet their training and development goals. 
* Responsible for meeting all production, safety and quality goals.

Production Line Manager

* Reduced changeover time by 50%, using the DMAIC process , SMED, and Poka-Yoke.

* Performed new equipment validations (IQ/PQ/OQ), and developed Change Management and Training documents.

Process Engineer

Georgia-Pacific LLC

Project Engineer

Schlumberger

* Collected and Analyzed data from oil wells to determine the feasibility of extracting oil and/or gas.

* Responsible for troubleshooting equipment failures in the field.

Offshore Field Engineer

I'm a former engineer and Edward Jones financial advisor who retired at 44, has worn many hats, and is now spending a lot of time doing what she loves 🙌


I launched The FI Woman LLC in 2015 with the initial mission of teaching women how to invest in the stock market so they could elevate their financial knowledge, take control of their finances, and feel empowered.


Since then, my mission has evolved to a more holistic approach. 


I balance professional expertise with personal experience to provide other first-gens in the US with financial guidance that is relatable and realistic.


I would love to connect and learn about you, and how we can work together. Send me a message or schedule a complimentary roadmap session using the link in my profile 🙏

taplio

The Battle

Judith Adair McCorry

Ramat Oyetunji CPFC®, MBA

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