Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice, is searching for a Validation Manager to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines where is required to work on-site presence for min 80% in Geel, Belgium 1.0 FTE, 6 months contract.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Main Job Tasks and Responsibilities:
* Oversee the various projects and corresponding resources (contractors), applying diligent project management practices and controls, to assure delivery vs plan.
* Assure quality and compliance (with internal and external regulatory requirements) of projects outputs & deliverables, while closely partnering with the corresponding Quality Assurance lead to assure full alignment.
* Drive change management to the broader organization to assure sustainable adoption of best practices.
* Mentor and coach the Local process owner (LPO) to uplift his/her knowledge to reflect industry best practices.
Education and Experience:
* Master’s Degree or equivalent.
* 8-10 years of work experience.
* Deep understanding and experience of computer system validation and data integrity in a pharma manufacturing environment.
* Experience in API environment preferred with knowledge of systems like DeltaV, PI, PCS7 along with practices as effective alarm management.
* Deep understanding of both FDA and EMA requirements towards CSV and Data integrity, including hands on experience with risk-based approaches and creation of validation documents.
* Excellent project management skills, organizing, planning and coordination skills.
* Experience in leading teams in complex / dynamic environments.
* Coaching, human change management and training skills.
* Ability to navigate politics, interact at different levels of the organization, and influence without authority.
* Good written and oral English communication skills; Dutch (preferred).
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Keywords: Validation Manager, CSV, API, Validation Document, Contract Research Organisation, CRO.
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