Global Quality Lead Cimzia, Commercial QA Immunology & Bone

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Date: Nov 15, 2018

Location: Braine L'alleud, Walloon Brabant, BE

Global Quality Lead Cimzia, Commercial

QA Immunology & Bone

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 Quality Assurance team, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of:

 

Global Quality Lead Cimzia, Commercial QA Immunology & Bone.


Are you known for your holistic approach with a collaborative nature? You are known as a ‘holiborative’ person at UCB. This incomparable blend of talent means you enjoy working contextually with others to optimize patient wellbeing.


As a UCB 'holiborative' person and Global Quality Lead Cimzia, Commercial QA Immunology & Bone you like to work in an environment where you can:

 

• Have interaction with a wide panel of stakeholders

• Work in full autonomy while being part of a global QA team

• Have career evolution opportunities


As a UCB 'holiborative' person and Global Quality Lead Cimzia, Commercial QA Immunology & Bone you will contribute by:


Global Quality lead: 

• Have the GMP quality oversight of the product

• Provide expert QA advice, support and management for technical operational QA and general QA matters for the supply chain for the product. Responsible for ensuring the routine Life Cycle Product Management activities are supported, ensures that all Lifecycle projects are supported.

• Lead the  Change Control Committee

• Lead the Global Complaints Committee

• Be the central point of contact for the organization for critical investigations/deviations/critical audit observations

• If recall decided at recall committee lead the recall execution and closure from a QA perspective

• Ensure Annual Product Stability studies overview • Write the Product Quality Review executive summary

• Ensure review and approval of regulatory CMC sections  linked to original submissions or variations

• Support preparation and execution of product launches from QA perspective (e.g. launch strategy, align QA activities, submission review, attend launch team meetings,etc.)

• Have the overview of UCB audit and inspections of CMOs and sites related to the product

• Facilitate inspection preparation at UCB or CMO sites  • Be the QA stakeholder for Product Risk management.

• Work closely with staff in the Corporate QA teams (especially CMC Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for the Product are provided in an effective and efficient way.

• Establish key performance indicators (metrics) for key operational QA activities and services associated with the Product

 

Project support:


Provide expert advice and support on operational and general GMP QA activities for projects part of the Commercial Immunology & Bone portfolio:
 
• Agree with team activities required for implementation

• Change controls - assessment in TrackWise, track closure of actions to submission approval

• Liaison with Regulatory Affairs

• Review and approve protocols and reports for Validation studies, Technology transfers, Comparability studies and Stability studies

• Review and approve submissions and responses

• UCB documentation review and approval

• Deviation review and approval during validation and technology transfer

 

General GMP:
 
• Maintain Quality System elements associated with the GMP activities in a compliant manner.

• Maintain key performance indicators (metrics) for key operational QA activities and services associated with Commercial Cimzia or other biological molecules activities.

• Maintain GMP compliance and inspection/audit readiness at all times. Support Head of Commercial QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments.

• Drive/Support projects related to quality system improvement


Interested? For this position you’ll need the following education, experience and skills:


• Minimum of 7 years working in the pharmaceutical biological industry in a GMP operational quality management position.

• In-depth knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques in particular related to manufacturing activities of biological products

• Experience interacting with third party organizations with respect to QA systems and regulatory inspection preparedness

• GMP Auditing expertise

• Ability to handle complex situations and interact/influence internal and external stakohlders

• Excellent interpersonal, verbal, and written communication skills in English

• Ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way


To apply please go to www.ucb.com/careers


Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers

 

 


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