Pharmavise Corporation

Consultant

• Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations.
• Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada, etc.).
• Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations).
• Design, execute, and oversee validation and qualification programs: Process validation Equipment qualification (IQ/OQ/PQ) Software/CSV (21 CFR Part 11) Cleaning and sterilization validation Computerized systems validation.
• Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements.
• Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks.
• Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management.
• Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables.
• Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training.
• Support change management, technology transfer, and scale-up initiatives for manufacturing and operations.
• Travel to client sites as needed.

GxP Senior Consultant – Subject Matter Expert

Content Marketing Manager

• Build, update, and maintain pages on internal SharePoint sites, including the Quality Culture Hub and related team sites.
• Configure SharePoint layouts, web parts, navigation, news posts, and document libraries.
• Troubleshoot site issues and make iterative improvements based on stakeholder feedback.
• Draft, edit, and publish communications across SharePoint, email, Teams, and other internal channels.
• Document page templates and update procedures for ongoing use.
• Design and produce high-quality visual, presentation, and video assets aligned with Client brand standards.
• Create polished PowerPoint templates and presentation decks for quality-related events, leadership updates, and engagement activities.
• Produce short promotional and explainer videos, typically 30–90 seconds, for internal campaigns, recognition, World Quality Week, and other quality culture initiatives.
• Develop digital banners, email headers, intranet graphics, Teams backgrounds, posters, printed site materials, infographics, animated graphics, and other engagement assets.
• Create materials suitable for SharePoint embedding, digital channels, and local printing or global site distribution.
• Manage an internal content calendar across SharePoint, Teams, and email.
• Post and update content directly across internal channels.
• Support social-style internal communications with strong attention to tone, cadence, engagement, and visual appeal.
• Coordinate reviews and approvals with the Quality Culture Engagement Sub-Team.
• Deliver ready-to-deploy materials on schedule.
• Build out and configure the centralized SharePoint Quality Culture Hub, including pages, navigation, web parts, and supporting libraries.
• Produce and publish Hub content, including patient stories, quality spotlights, short videos, and resource libraries.
• Own post-launch content refreshes, page updates, and ongoing site maintenance.

Quality Culture Communications & Digital Content Specialist

Project Manager

• Lead and manage cross-functional projects within pharmaceutical, biotechnology, and/or medical device environments
• Develop and maintain project plans, timelines, budgets, risk registers, and status reports
• Coordinate project activities across Quality, Regulatory, Engineering, Validation, Manufacturing, Clinical, and Supply Chain teams
• Facilitate stakeholder meetings and communicate project updates to client leadership and internal teams
• Identify project risks, issues, and mitigation strategies to ensure successful project execution
• Support project governance, resource planning, prioritization, and execution activities
• Ensure projects align with applicable GxP, FDA, ISO, and industry compliance requirements
• Drive accountability, action item tracking, and project deliverables across multiple stakeholders
• Support continuous improvement and operational excellence initiatives
• Maintain strong client relationships and represent Pharmavise professionally in client-facing environments.

• As an Associate Project Manager, you will lead sustaining projects on the Urology Project Management team.
• You will collaborate cross-functionally and internationally to drive projects that are critical to business growth and continuity.
• You will join a team of passionate individuals striving to improve patient care.
• Partner and collaborate with a variety of functions, regions, and business resources to achieve project objectives
• Generate and implement project plans, communications, and schedules to assist with task prioritization and workload adjustments to maximize team potential
• Manage project challenges including scope impact assessments and recommended solutions
• Build team ownership and commitment to project plan and identify, manage, and communicate project risks
• Interact with senior leaders on complex matters requiring coordination between organizations
• Prepare and deliver project status updates to management
• Document risk mitigation plans, decision logs, meeting minutes, project metrics, and other key communications
• Ensure current policies and practices are followed
• Identify resources required for project activities, develop project budgets, resource allocations and timelines
• Effectively lead global project teams ensuring good cross-functional communications and alignment on priorities amongst projects
• Assist with Annual Operating Plan (AOP), making sure all sustaining project requests & associated resourcing are accounted for
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Associate Project Manager – Medical Device

• Partner and collaborate with a variety of functions, regions, and business resources to achieve project objectives
• Generate and implement project plans, communications, and schedules to assist with task prioritization and workload adjustments to maximize team potential
• Manage project challenges including scope impact assessments and recommended solutions
• Build team ownership and commitment to project plan and identify, manage, and communicate project risks
• Interact with senior leaders on complex matters requiring coordination between organizations
• Prepare and deliver project status updates to management
• Document risk mitigation plans, decision logs, meeting minutes, project metrics, and other key communications
• Ensure current policies and practices are followed
• Identify resources required for project activities, develop project budgets, resource allocations and timelines
• Effectively lead global project teams ensuring good cross-functional communications and alignment on priorities amongst projects
• Assist with Annual Operating Plan (AOP), making sure all sustaining project requests & associated resourcing are accounted for

Clinical Research

• Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high performance, collaborative team environment.
• Oversee end to end operational execution of global clinical trials, ensuring adherence to protocol, GCP, SOPs, and applicable regulatory requirements.
• Translate program strategy into operational plans, timelines, and resource needs; ensure cross functional alignment and timely delivery of study milestones.
• Oversee development and maintenance of study documentation, including operational plans, study materials, systems, and regulatory submissions.
• Manage CROs and external vendors, including selection, contracting, performance oversight, issue escalation, and budget tracking.
• Lead proactive risk identification, mitigation planning, and contingency management across assigned studies.
• Provide clear, data driven study updates, risk assessments, and recommendations to clinical leadership and governance bodies.
• Manage clinical trial budgets, including forecasting, accruals, variance analysis, and financial oversight of vendor contracts.
• Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment, engagement, and study success.
• Ensure inspection readiness and compliance with internal quality standards, audit findings, and regulatory expectations.
• Champion continuous improvement in clinical operations processes, tools, and best practices.

Senior Clinical Trial Manager – Medical Device

Software Engineer

• Support pharmaceutical manufacturing operations by applying engineering principles and expertise to optimize processes, equipment, and facilities.
• Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to ensure efficient and compliant manufacturing operations.
• Lead or participate in process improvement initiatives, including the identification, evaluation, and implementation of new technologies, equipment, and manufacturing practices.
• Conduct risk assessments and develop risk mitigation strategies for manufacturing processes, equipment, and facilities to ensure product quality and compliance with regulatory requirements.
• Provide technical support for troubleshooting manufacturing issues, deviations, and investigations, and implement corrective and preventive actions (CAPAs) as needed.
• Support the design, installation, qualification, and validation of manufacturing equipment and facilities, including process equipment, utilities, and cleanrooms.
• Develop and maintain manufacturing documentation, including standard operating procedures (SOPs), batch records, and equipment qualification/validation documentation.
• Stay abreast of industry trends, advancements, and regulatory requirements in pharmaceutical manufacturing and engineering, and apply best practices to drive continuous improvement.

GxP Senior Consultant – Subject Matter Expert

Quality Culture Communications & Digital Content Specialist

Project Manager

Associate Project Manager – Medical Device

Associate Project Manager – Medical Device

Senior Clinical Trial Manager – Medical Device

Pharmaceutical Manufacturing Specialist – Engineering Background