Quality & Regulatory Technology & Innovation - Remote

PharmaLogic Holdings Corp.; Northern (KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

PharmaLogic Holdings Corp. is seeking a Quality & Regulatory Technology & Innovation Program Manager to lead the development and deployment of AI, automation, analytics, and digital transformation across Q&R operations in the United States.

You will partner with Q&R leadership and cross-functional teams to translate regulatory needs into practical tech solutions, build AI-enabled tools, and ensure governance with IT and enterprise platforms like eQMS and LIMS.

Qualifications

• Bachelor's degree in IT, CS, data analytics, engineering, business, pharma sciences, or related field.
• Minimum 5 years of tech, data analytics, automation, digital transformation, or related roles.
• Experience translating business requirements into scalable technology solutions.
• Demonstrated hands-on experience designing and implementing generative AI-enabled solutions, agents, automated workflows, or other tech solutions.
• Advanced experience with Microsoft Power BI, including dashboard development and metrics.
• Strong working knowledge of Microsoft 365 and AI platforms (Copilot, ChatGPT, Claude).
• Experience in regulated pharma/healthcare environments with quality requirements.
• Demonstrated ability to analyze complex processes and improve performance.

Responsibilities

• Develop and implement the Q&R technology roadmap leveraging AI, automation, analytics, and digital tech.
• Design, build, test, and transition AI agents, dashboards, and automated workflows.
• Partner with IT and business units to ensure governance, security, and data integrity.
• Create scalable data collection and ESG/regulatory data tools.
• Deliver prototypes and proofs of concept for emerging tech.
• Lead cross-functional technology initiatives from concept to adoption.

Skills

Power BI

AI & automation

Data analytics

Digital transformation

Project management

Cross-functional collaboration

Regulatory compliance awareness

Education

Bachelor's degree in Information Technology, Computer Science, Data Analytics, Engineering, Business, Pharmaceutical Sciences, or related field

Tools

Microsoft 365

Copilot Studio

ChatGPT

Claude

Job description

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Quality & Regulatory Technology & Innovation - Remote

Full-time Regular Remote, 0, 0, US

Salary: $130,000.00 Annually

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

Role: Quality & Regulatory Technology & Innovation Program Manager

Reports to: VP, Quality and Regulatory

Quality & Regulatory Technology & Innovation Program Manager

The Quality & Regulatory Technology Program Manager is responsible for supporting the development and implementation of the technology, artificial intelligence (AI), automation, data analytics, and digital transformation roadmap for Quality & Regulatory (Q&R) operations within the United States.

This position partners closely with Quality & Regulatory leadership and functional teams to identify opportunities where technology can improve quality oversight, regulatory compliance, data visibility, operational efficiency, and employee effectiveness.

The Program Manager serves as a hands-on technology and innovation resource within Q&R, translating business and regulatory needs into practical technology solutions. The position will design, build, test, implement, and transition AI agents, analytics tools, dashboards, automated workflows, and other digital solutions to functional teams for ongoing use. The role will also partner closely with Information Technology (IT) and other enterprise stakeholders to ensure solutions align with organizational technology, security, data, and AI governance requirements.

Partner with Q&R leadership and functional teams to develop and implement the Q&R technology roadmap, identifying and prioritizing opportunities to leverage AI, automation, analytics, and emerging technologies across Pharmacy Quality & Regulatory, Manufacturing Quality & Regulatory, Radiation Safety, and related functions.

Evaluate Q&R workflows and administrative processes to identify opportunities for automation and efficiency, and develop scalable technology solutions that reduce manual effort, eliminate redundant activities, improve consistency, and allow Q&R professionals to focus on higher-value activities.

Design, build, test, and implement Power BI and AI-enabled tools and agents that improve Q&R processes, reduce administrative burden, enhance access to information, support decision-making, actionable insights, and improve employee productivity, using approved technologies.

Develop data collection and management tools supporting Q&R business needs, including systems and workflows that facilitate the collection, organization, validation, and accessibility of ESG metrics and other operational, quality, regulatory, and compliance data.

Partner with Q&R functional teams and system owners on the implementation and optimization of enterprise platforms, including eQMS, LIMS, and other Quality and Regulatory systems, identifying opportunities to layer analytics, AI, automation, and complementary technology solutions into established platforms and workflows.

Develop prototypes and proof-of-concept solutions to evaluate emerging technologies, assess business value and feasibility, and establish scalable approaches for successful solutions before transitioning them to functional teams for ongoing operation.

Establish sustainable processes for technology solutions, including appropriate documentation, user guidance, training, data definitions, ownership, maintenance expectations, and knowledge transfer to ensure tools can be effectively operated and maintained by Q&R teams.

Monitor emerging AI, analytics, automation, and digital technologies and recommend opportunities that could enhance Quality & Regulatory compliance, operational performance, data-driven decision-making, or employee effectiveness.

Required Qualifications

Bachelor's degree in Information Technology, Computer Science, Data Analytics, Engineering, Business, Pharmaceutical Sciences, or a related technical, scientific, or business discipline.

Minimum 5 years of progressive experience in technology, data analytics, automation, digital transformation, or related roles,

Experience translating business requirements and complex workflows into scalable technology solutions.

Demonstrated hands-on experience designing and implementing generative AI-enabled solutions, agents, automated workflows, or other technology solutions used in business operations.

Advanced experience with Microsoft Power BI, including dashboard development, data modeling, visualization, and development of actionable business metrics.

Strong working knowledge of Microsoft 365 and AI platforms such as Microsoft Copilot, ChatGPT, and Claude, with demonstrated ability to apply these technologies to practical business processes.

Experience working in a pharmaceutical, healthcare, life sciences, manufacturing, or other regulated environment with an understanding of Quality and Regulatory processes and requirements.

Demonstrated ability to analyze complex processes, identify inefficiencies, and develop practical technology solutions that improve performance and reduce administrative burden.

Strong data literacy with experience organizing, integrating, analyzing, and presenting information from multiple data sources.

Strong project and program management skills with demonstrated ability to lead cross-functional technology initiatives from concept through implementation and adoption.

Strong communication and interpersonal skills with the ability to work effectively with technical teams, functional subject matter experts, operational leaders, and senior leadership.

Ability to independently develop solutions while effectively partnering with IT, vendors, and functional teams on larger technology initiatives.

Evangelize technology adoption and digital capability across Q&R to help functional teams effectively use AI, automation, analytics, and other approved technologies.

Preferred Qualifications

Advanced experience with AI agents, generative AI, prompt engineering, workflow automation, Microsoft Power Platform, Copilot Studio, APIs, or other low-code/no-code development technologies.

Experience developing enterprise dashboards, quality metrics, executive reporting tools, or analytics solutions within pharmaceutical or healthcare environments.

Experience supporting pharmaceutical Quality Management Systems, regulatory operations, pharmacy operations, manufacturing quality, radiation safety, or related regulated functions.

Experience supporting implementation or optimization of eQMS, LIMS, or other regulated enterprise systems.

Experience developing AI governance frameworks, standards, or procedures within regulated environments.

Experience developing data collection and automation solutions supporting ESG or sustainability metrics.

Lean Six Sigma certification or demonstrated experience applying Lean, Six Sigma, or other continuous improvement methodologies.

Experience leading technology adoption, change management, training, and knowledge transfer initiatives.

Starting Annual Salary - $130,000.00

PharmaLogic is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.