Qualification Services Project Manager
Be part of something altogether life-changing**:
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health.
Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients.
With associates across 40 countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
**Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies.
Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
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**What you'll do
As a result of our growing customer needs to ensure maximum lifecycle utilization of their equipment, we are looking for a Global Services Qualification Services Project Manager.
- 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.
- Act as escalation point and respond/resolve internal & external issues requiring management intervention
- Support customer meetings as needed
- Visit customer sites as needed to kick off projects and ensure proper execution of protocols at the site.
- Work cross functionally with other function in qualification services.
- Leverage DBS as appropriate
- Travel as needed - 10-15%
**Who you are
- Bachelor's degree in Science, Engineering or related area or relevant work experience.
- Minimum 5 Years of experience in a customer facing role managing complex equipment's implementation projects.
- Experience from biopharma industry as well as understanding of cGMP compliance and 21 CFR Part 11 is an advantage.
- Experience with Risk-Based Approach to Commissioning and Qualification, is considered a plus.
- 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 is beneficial.
- 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.
- Demonstrated ability to excel in a fast-paced environment.
- Demonstrated ability to navigate complex matrix organizations.
- Strong knowledge on Upstream and Downstream equipment's architecture with proven ability to understand the C&Q verifications associated to each technology.
- Strong customer and commercial acumen will be considered a plus.
- Strong knowledge of technical service support organizations will be considered a plus.
When you join us, you'll also be joining Danaher's global organization, where 68, 000 people wake up every day determined to help our customers win.
As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard.
We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.
**If you've ever wondered what's within you, there's no better time to find out.
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