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

Sanofi

•Deviations Support – Risk Assessments and Closures
•Audits, walk-throughs, GEMBAs, technical coaching
•Review Documentation – Logbooks, SRNs, Daily Releases, Batch Records, etc.
•Aseptic behavior review and coaching
•Aseptic Process Simulations / Interventions Observations
•Provide direct shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs.
•Provide guidance to resolve compliance issues and procedural errors in real time.
•Perform periodic shop floor audits/walk-throughs.
•Enhance technical knowledge of operators and shop floor managers by providing positive
and constructive feedback.

Quality Compliance Official

• Prepare biological media, stock solutions, and buffers according to standard operating procedures to meet or exceed turn-around-time expectations; calculate media protocol changes as needed
• Record accurate batch records with a methodical approach to media making
• Produce requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures.
•Complete tasks and corresponding documentation as required by cGMP.
• Prepare for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling and weighing materials and supplies.
• Hands-on operation of physical and automated equipment to perform fermentations and downstream processing
• Maintain safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
• Participate in all aspects of inventory management (SAP, cycle counting, ordering, etc.).

Fermentation - Vaccine

Advanced Coordinating Officer for Protective Services

•	In charge of delivering resourceful audio/visual surveillance services for estate, insurance, infidelity investigations, suits, identity theft, healthcare / health insurance fraud, credit card fraud, workers compensation fraud, reverse mortgage scams, as well as background investigations
•	Responsible for monitoring and providing accurate reports, containing detailed subject information and gather, analyze, compile and report information regarding individuals or organizations to clients
•	Detect occurrences of unlawful acts or infractions of rules in private establishment 
•	Confer with establishment officials, security departments, police, or postal officials to identify problems, provide information, or receive instructions and collaborate with law enforcement or security agencies to respond to incidents 
•	Search computer databases, credit reports, public records, tax or legal filings, or other resources to locate persons or to compile information for investigations

Investigative Specialist

LeFrak

•	Overseen the planning, management, and coordination of access control related operations
•	Held responsibility for access card and key security, inventory control, database management, electronic products system management, supervision, vendor/contractor management, and the overall management of the residential and commercial access and key control program
•	Provided consultation, recommendations, and technical expertise and support
•	Advised department leaders and administrators on access control matters and served as a resource to all of POC
•	Researched and evaluated emerging access control technology such as new hardware, software, and management tools relating to access control, facilities, access card and key control, and security
•	Managed provision, distribution, and tracking of access cards and keys and developed and maintained an inventory control database for access cards and key blanks that were issued and purchased
•	Collaborated, developed, and supported departmental initiatives, policy proposals, and strategic plans
•	Defined, developed, and directed the scope, operational priorities, standards, policies, and implementation plans including milestone and performance metrics for access control projects
•	In charge of the management of materials, parts, equipment, and expenses including inventory tracking, record keeping, product research, and supply procurement
•	Ensured technology based systems were maintained with current software and firmware revisions were routinely backed-up for data retrieval, and routinely tested for emergency power transfer and continuing operations during power failure
•	Developed training programs, and instructed personnel on access control related topics
•	Worked in collaboration with Security Systems Specialist, Security Systems Project Manager, Insurance and Risk Management, and Public Safety to define, recommend, and implement access control and security policies and standards

Security Specialist

NJ-NY Immigration Law Offices

•  Managing the caseload from intake through processing and filing.
•  Preparing of removal defense filings.
•  Preparing applications for permanent residency and secondary benefits for foreign nationals.
•  Processing and filing nonimmigrant and immigrant visa petitions.
•  Organizing petition packets for review and filing.
•  Gathering application and petition information from external parties.
•  Keeping clients apprised of the progress of their cases.
•  Maintaining hard copy files and entering data into an immigration case management system.
•  Responding to immigration inquiries in a timely manner and adhering to submission deadlines

Immigration Law Clerk

Hudson County Public Defender

•	Assisted Hudson County Public Defenders with clients.
•	Investigated cases, interviewed clients and witnesses, conducted legal research, helped with motions, and participated in all phases of trial preparation
•	Help draft memos and legal pleadings and help prepare for hearings and other tasks.
•	Participated in various aspects of criminal defense work.
•	Worked with members of the office, community, and representatives of other agencies.
•	Court and investigation participation and observation.
•	Worked very closely with Hudson County Prosecutor’s office for all trial preparations.

Internship

Solutions-focused, highly skilled professional with excellent analytical thinking and strong deductive reasoning competencies.  As such, I possess exceptional knowledge, skills, and abilities in pharmaceutical, vaccines, quality, compliance, quality assurance, regulatory, criminal, operational, logistical, administrative, and oversight functionalities.  I am capable of effectively defining, developing, and implementing target action plans which promote operational productivity, as well as provide efficiency with minimal supervisory oversight or management review.  I have developed a reputation for integrity, reliability, accompanied with a work ethic which promotes only the highest professional standards.  I am also capable of demonstrating ability to independently plan, coordinate, conduct, report, and work collaboratively with other groups and institutions.

taplio

The Battle

Judith Adair McCorry

Hena Parhar-Williams, MS, ISSO, CNNSI

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