Mgr Corporate QA CMC Dev Biosciences
Mgr Corporate QA CMC Dev Biosciences
Date: Jun 3, 2019
Location: Braine L'alleud, Walloon Brabant, BE
Manager, Corporate QA, CMC development
BioSciences Global Quality Assurance
Location: Braine-L'Alleud, Belgium
Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?
To strengthen our Development Quality BioSciences, based in our Global Quality Assurance Department in BraineL'Alleud, Belgium, we are looking to fill the position of: Manager, Corporate QA, CMC development, BioSciences.
Are you inspiring in the business of partnering? At UCB this makes you an 'inspartnering' person. This specific blend of talent means you excel at getting the right heads together to stimulate positive change for patients.
As a UCB 'inspartnering' person and Manager, Corporate QA, CMC development, BioSciences you like to work in an environment where you can:
* Lead QA project related activities in support of Product Development and the running of Development processes and facilities. Thereby ensuring that all activities performed in support of product development are conducted in a way that ensures product quality, meets regulatory requirements and delivers business performance.
* Be responsible for partnering with other UCB departments to ensure Quality Assurance support for product development activities in order to identity, mitigate and resolve compliance and quality issues that may affect UCB activities but also for liaising with business partners in order to ensure consistent approach globally to the management of Product Development activities in accordance with UCB's policies and procedures.
As a UCB 'inspartnering' person and Manager, Corporate QA, CMC development, BioSciences you will contribute by:
* Providing strategic and practical support to increase efficiency, reduce costs and meet cGMP requirements.
* Interacting with other functional department to provide product to meet stakeholder expectations.
* Identifying significant issues to upper management and providing solution options.
* Communicating roles in the Quality Assurance & Services organizations.
* Maintaining an SOSD (See it, Own it, Solve it, Do it) culture throughout the organization. Maintain a Quality philosophy.
* Ensuring that all operations are in accordance with applicable regulations (EMEA, FDA, DEA, MHRA, OSHA, DEC, etc. where relevant).
* Ensuring communication of compliance status and issues to the highest levels of the organization.
* Participating in identifying, developing and implementing quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.
* Ensuring efficient and effective business processes to achieve business development goals.
Interested? For this position you'll need the following education, experience and skills:
Experience and background:
* At least a Bachelor's degree and minimum 8-year experience in pharmaceutical regulated environment
* Must be knowledgeable in regulatory and technical requirements of the pharmaceutical industry, have interacted directly with regulatory agencies, and have a strong management background.
* A comprehensive knowledge of current regulatory requirements and ability to interpret current regulations is required.
* A comprehensive understanding of business/operational needs
* Experience in audits and regulatory inspection and due diligence. QA/compliance experience in Biologics development, manufacturing, facility operation, laboratory compliance and quality system Areas of expertise should include most, if not all the following: regulatory affairs and compliance, quality assurance and controls, validation, technical services, and an in-depth knowledge of at least one scientific field related to pharmaceutical sciences.
* Experience with a broad range of dosage forms (solids, liquids, sterile) and biologicals is essential.
* Excellent interpersonal, verbal, and written communication skills are required, with ability to balance multiple priorities, provide leadership and prioritisation, and work with minimal supervision.
* Good teamwork and project management skills. Must be detail oriented with strong managerial, organization, leadership and analytical skills.
* Fluent in English, any other language is an asset.
* Facilitator and planner with excellent people skills and cultural awareness.
* Well organised with the ability to see the bigger picture.
* Knowledge of cGMP and appropriate regulations (eg US, European, Japanese).
* Fact based decision maker: understand complex issues and could make informed decisions when working on "grey" issues.
* Willing to travel. Able to make quality/compliance decisions in a business environment.
* Has a forward-thinking attitude towards GMP and regulatory compliance.
* Knowledge of FMEA, Kepner Trigoe and other complex problem-solving tools.
* Experience in failure investigation process.
* Familiarity with risk assessment tools.
* Able to interact with internal (such as UCB functional areas) and external (such as FDA, EMEA and other regulatory authorities) major contacts.
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