Judith A. Email & Phone Number

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.

Burlington, Vt, Us

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.

Burlington , Vt, Us

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.

Burlington , Vt, Us

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.

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.

Clarkston, Michigan, Us

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.

Boxborough, Massachusetts, Us

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.

Gaithersburg, Maryland, Us

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.

Rahway, New Jersey, Us

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 .

Rahway, New Jersey, Us

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

Rahway, New Jersey, Us

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

Rahway, New Jersey, Us

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

Rahway, New Jersey, Us

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

Wilmington, Nc, Us

Analyzed biopharmaceutical drugs for release and stability testing from pre-clinical to commercial stage ▪ Updated and maintained reference standard inventory and certification ▪ Coordinated with stability group to ensure availability of laboratory supplies

New York, New York, Us

Project study coordinator for stability testing of preclinical, phase I, and phase II clinical products ▪ Authored new SOPs, stability protocols, stability study project summary and reports, and raw material specifications ▪ Supported quality control microbiology lab with growth promotion and reagent qualification, microbial identification and environmental monitoring ▪ Oversaw raw material testing and inventory for the manufacturing group

Us

Tested bioburden of media, bioreactor, and water samples in support of process qualifications and new drug campaigns for Pilot Plant ▪ Assisted in sample submission and reading EM plates ▪ Gained extensive experience with SOPs, GMPs, and trained in a matrix-based structure

Hanover, Maryland, Us

Tested aseptic and non-aseptic sites; release of Class 100 Room for the production of Anti-Infective pharmaceuticals; environmental monitoring before, during and after production ▪ Revised SOPs and authored/conducted OOS investigations ▪ Operated AMSCO autoclave for decontamination of waste materials.

Master Of Business Administration - Mba

Master'S Degree, Leadership Development

Bachelors Of Science, Biochemistry

Education record