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Full-time
bachelor degree
Posted 9d ago
~40 hrs/week
Remote in Slovakia
Responsibilities
The Senior Operations Specialist manages initiatives to improve operational efficiency and quality across business processes. They lead change management efforts, facilitate root-cause problem-solving, and collaborate with cross-functional leadership to implement strategic improvements.
Requirements
Candidates must have a bachelor's degree and 5-7 years of experience in operations support, process improvement, and change management. Strong knowledge of drug development, ICH-GCP regulatory guidelines, and proficiency in Microsoft Office are required.
Full job description
Job Summary and Purpose:
The Senior Operations Specialist leverages expertise and knowledge to plan and manage initiatives and activities designed to improve the quality, efficiency and effectiveness of the delivery of studies to Sponsors. The Sr Operations Specialist develops and implements processes, change management plans, standards or operational plans with the goal of operational excellence across the business collaborating across a group of diverse stakeholders.
They will support a wide range of activities within the Business & Operational Excellence group. Specific tasks depend on the functional area, including Process improvement, support of training content and/or development and deployment of change management initiatives. This role executes functional priorities with minimal oversight.
Main Duties & Responsibilities
Support the vision of and commitment to continuous improvement in operational excellence across all activities.
Lead the evaluation of business processes and workflows to identify opportunities for improvement or automation under direction of a supervisor.
Participate with stakeholders in root-cause problem-solving techniques to identify core process challenges.
Support the development of recommendations for process improvement, leveraging subject matter experts for critical input.
Partner with cross functional leadership to prioritize improvement opportunities and support strategic initiatives.
Partner on the design and implementation of new business processes with organizational context and priorities in mind.
Lead change management initiatives and support business through a communication framework assessment of impact on roles and deploy a variety of tactics to support change management effort to ensure adoption and sustainability of process changes.
Lead internal communication to effectively update stakeholders on progress, performance, key issues, and blockers that may impact business attainment or critical program and project completion
Identify operational risks and lead implementation of mitigation plans.
Ensure or lead the documentation of business process.
Work with leadership to establish key performance metrics and dashboards for monitoring operational performance.
Provide insight into training and guidance to teams on new processes and how to identify improvement opportunities, building awareness on continual improvement initiatives
Support standardized best practices and processes across the organization to ensure consistency and sustainability.
Monitor, measure, and analyze the effectiveness of new initiatives and processes, making adjustments as needed.
Monitor adoption of process, system and organizational changes to ensure long term and sustained adoption.
Prepare and maintain tools and templates to support execution
Schedule meetings, take notes, and track actions
Travel as needed
Education and Experience:
Minimum:
Bachelor's degree or equivalent experience
5-7 years in change management, operations support, and process improvement experience
Experience in CRO/pharmaceutical/biotechnology drug development or demonstrated competency in the key areas of the role
Strong drug development experience with understanding of other functions relevant to the position.
Knowledge, Skills, and Competencies:
Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams)
Strong written and verbal English communication skills
Knowledge of ICH-GCP and regulatory guidance
Strong interpersonal and training skills
Self-motivated and detail-oriented
Ability to work independently and in teams
Strong professionalism, sense of ownership and pride in quality of outputs
Understanding of change management models (ie ADKAR) and use of change radars
Flexible attitude with respect to work assignments and ability to thrive in a fast-paced dynamic environment
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.
Project Farma is a patient-focused global leader in advancing technical operations from ideation through commercialization with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations for complex biologics and novel modalities. We provide end-to-end services for the entire manufacturing lifecycle for pharmaceutical and biotech companies, universities, hospitals, and government agencies. Project Farma has executed 100+ facility builds, retrofits and expansions, managed 400+ large scale capital projects, industrialized 10+ commercial cell, gene, and novel therapies, and managed $6B+ in technical operations capital investments.
One of our core values is giving back. Volunteering at hospitals, supporting life science related fundraisers and partnering with nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but we also bring our team and our client’s team closer to the actual patients and families that will be impacted by our work.
Project Farma is a PerkinElmer company. (https://www.projectfarma.com/)
Offices: 710 Bridgeport Ave, Shelton, Connecticut 06484, US
Cleaning Validation Compliance & Quality Assurance Commissioning & Qualification Computer Systems Validation Controls & AutomationEnvironmental MonitoringEngineeringFinancial Strategy Process Validation Program Management
Project Farma is a patient-focused global leader in advancing technical operations from ideation through commercialization with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations for complex biologics and novel modalities. We provide end-to-end services for the entire manufacturing lifecycle for pharmaceutical and biotech companies, universities, hospitals, and government agencies. Project Farma has executed 100+ facility builds, retrofits and expansions, managed 400+ large scale capital projects, industrialized 10+ commercial cell, gene, and novel therapies, and managed $6B+ in technical operations capital investments.
One of our core values is giving back. Volunteering at hospitals, supporting life science related fundraisers and partnering with nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but we also bring our team and our client’s team closer to the actual patients and families that will be impacted by our work.
Project Farma is a PerkinElmer company. (https://www.projectfarma.com/)
Offices: 710 Bridgeport Ave, Shelton, Connecticut 06484, US
Cleaning Validation Compliance & Quality Assurance Commissioning & Qualification Computer Systems Validation Controls & AutomationEnvironmental MonitoringEngineeringFinancial Strategy Process Validation Program Management