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

GeneFab

GeneFab is a spin out of Senti Bio and offers PD, AD, and GMP services in cell therapy and viral vectors, manufacturing, and drug design in Synthetic Biology.

Senior Vice President, Business Development

Manage, plan, and direct all activities of Commercial organization, including Business Development, Marketing, Product Management, and PMO.  Provide strategic and organizational leadership to Vernal's CDMO mRNA and LNP business for vaccine and cell and gene therapy.

Senior Vice President, Commercial Operations

Synthego Corporation

Business leader for clinical GMP services enabling cell and gene therapies, including GMP sgRNA manufacturing and sgRNA-RNP partnership
Drive product roadmap, pricing, sales, and go-to-market strategy for GMP products and gene editing services provided by Synthego
Drive and close GMP sgRNA deals

Senior Director, GMP Products

TriLink BioTechnologies, part of Maravai LifeSciences

Direct product management and P&L for enterprise products (CleanCap) and CDMO services for GMP pDNA and mRNA. Closed partnership deals and run QBRs. Took on additional responsibilities to manage Inside Sales and Customer Success teams.

Director, Product Management

REPROCELL

Direct consultative sales, BD and CRO service strategies for mRNA reprogramming and CRISPR services for induced pluripotent stem cells (iPSC).
Manage commercial development activities enabling iPSC-based cell therapy applications. A deal hunter, built pipelines and closed deals.

Business Development Manager, iPSC and Gene Editing

MilliporeSigma

Product and marketing manager for CDMO and GMP bioprocessing in viral vector applications.

Sr Product and Marketing Manager, Cell and Gene Therapy

FUJIFILM Irvine Scientific

Team lead of 4 product marketing managers and inside sales.
Product manager for GMP cell culture portfolio from conceptualization to commercialization through phase-gated product development. 
Launch and manage cell therapy P&L in high growth areas.
Capture and utilize VOC for new product development and product improvement.
Product champion in cell therapy, immunotherapy and cancer vaccines (market competition, technical knowledge, pricing and positioning). Direct product management team for cGMP cell culture business line.
Plan go-to-market strategies and drive >98% profitable growth YOY. 
Accomplish sales organization objectives by identifying and capitalizing marketing opportunities based on various emerging cell therapy, CAR-T and clinical applications and key requirements in cell and gene therapy.

Product and technical support for Life Science.
Product specialist in stem cells, molecular biology, antibodies, protein expressions, OEM and IVD.
Managed IVD, OEM, Custom and Bulk product support for key and target accounts.

Sr Technical Support Specialist

University of California, Riverside

CIRM iPSC Core Manager, providing CRO services and leading a team of PhD candidates and staff scientists.
Derived Riv human iPSC lines (e.g. Riv9, XY) that are widely used and cited in peer-reviewed journals.
As a Principle Investigator, executing multiple stem cell research projects.
Managed daily operation of Stem Cell Core - iPSC distribution, CIRM Bridges training,  supervision of lab manager, technicians, MSc graduate students and STEM undergraduate researchers.

Manager, CIRM Stem Cell Core

UC Irvine School of Medicine

California Institute for Regenerative Medicine (CIRM)-funded postdoctoral fellow:
Differentiation of human induced pluripotent stem cells (HIPSC) and HESC

CIRM Postdoc - School of Medicine

CDMO commercial leader in cell and gene therapy.  Successful track record in building and expanding Commercial organizations for all sales functions, including business development and marketing with direct experience in mRNA, LNP, iPSC, immuno-oncology, and gene editing.

taplio

The Battle

Judith Adair McCorry

Duncan Liew, PhD

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