Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics.
Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies.
Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
We are looking for a SENIOR PROJECT MANAGER, QUALIFICATION SERVICES to work with our expert QUALIFICATION SERVICES team of approximately 50 employees across the world.
Do you have a passion for COMMISSIONING / QUALIFICATION and PROJECT MANAGEMENT ?
Then we would love to hear from you.
What you’ll do
Lead Commissioning and Qualification projects for large scale pharmaceutical production projects.
Communicate current state to customers and senior management to secure deliverables.
Manage all customer project milestones deliverables; handle urgent tasks, regional communication to display actions made and in progress.
Cooperate and communicate with cross functional project leaders and key stakeholders to secure qualification product deliverables.
Manage quality objectives, regulatory requirements, schedules, program risks and making decisions based on business objectives.
Ensure compliance / closure of regulatory and quality requirements before approving program milestones.
Maintain budget and timelines.
Identify and assess changes in scope.
Who you are
Bachelor's degree in Science, Engineering or related area or relevant work experience.
Demonstrable understanding and work experience of cGMP compliance knowledge including knowledge of 21 CFR 210, 211, 820, ISPE guidelines, PICS Guide to Good Manufacturing Practices, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, ICH and Part 11 compliance knowledge.
Comprehensive knowledge of Validation lifecycles for Computerized Systems and Process Control Systems.
Experience with the development and implementation of current validation systems in the pharmaceutical industry and how they relate to regulatory requirements and cGMP regulations within the EMA, CDA and US FDA.
Experience with Risk-Based Approach to Commissioning and Qualification.
Experience in developing and generating requirement traceability metrics.
Extensive working knowledge of upstream equipment, downstream equipment and automation infrastructure and automation platforms.
Demonstrated knowledge and experience working with the project management life cycle.
Demonstrated capability of cross-functional and cross-site interactions and ability to drive project plans to completion.
Experience interacting with regulatory and third-party representative.
Demonstrated ability to effectively manage multiple projects / priorities and approaches to meet objectives.
Excellent communication skills including the ability to effectively communicate across organizational levels and functions.
Facilitate open communication and sharing of knowledge.
Demonstrated ability to excel in a fast-paced environment.
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs, Box, modular documentation, document handling systems, IRCA and Oracle based applications.
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here.
If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.