Head of External Manufacturing Quality Operations
il y a 3 semaines
**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better. To achieve that, we need the brightest minds and biggest hearts. That’s why our Talent Acquisition Team looks for passionate people inside and outside the company. Are you interested in an internal move that will allow you to explore how much more you can do to make a difference for people living with severe disease?
To strengthen our **Quality Assurance **team, we are looking for a talented individual to fill the position of **Head of External Manufacturing Quality Operations Bio DS** based in Braine-l’Alleud, Belgium.
This position will oversee the operational activities associated with the disposition of drug substances Biologics, starting materials and intermediates produced by third parties for commercial purposes. This will be achieved through close working and partnering with Quality colleagues, UCB DMSO (Development, Manufacturing, Supply Operations), Regulatory and external parties. This Position will ensure global quality oversight of External Manufacturing Inspection Readiness & External Network Governance.
The role will be part of the GMP/GSP Quality Operations Leadership team.
The position will provide strategic and operational leadership to the team of Vendor Quality Leads and provides QA expertise in driving strategic and operational Quality Assurance activities associated with Drug Substances Biologics Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products.
This will be achieved through close partnering with Senior QA management within UCB and includes interfaces with the Heads of External manufacturing Ops. DS/DP/Devices, Head of External Manufacturing Supply Chain, Head of External Network Governance and many Quality colleagues.
**Main accountabilities**:
Leading a team of Drug Substance Vendor Quality Leads (VQL) and related accountabilities:
- Lead, manage, and motivate a team of Vendor Quality Leads (VQL)
- Establish and build a network with UCB key stakeholders in relation to External Manufacturing of UCB Drug Substance
- Coach and lead a team of Quality professionals to providing expert advice, support and management for technical operational QA and general QA matters related to the Strategic vendor relationship. The team has a focus on the following:
- Negotiation and review of Quality Agreements
- Leading complex investigations related to Quality
- Performing focused assessments/audits
- Own vendor change control governance processes
- Perform reviews of GMP documents
- Provide on-site presence at vendor
- Drive CAPA implementation at vendors through close monitoring
- Ensure execution of Annual Product Stability studies and Product Quality
- Product Quality Reviews at the vendors
- Ensure systems alignment between vendor and UCB
- Facilitate quality improvement activities at vendors and UCB systems
- Support projects associated with the products
- Release of the DS
- Build, establish, and develop a governance model and process for Quality oversight of drug Substance Biologics vendors which fosters continuous quality process improvement and key indicator-based performance monitoring of the vendors
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
- Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
- Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
- Upon request deputize for the Head of External Manufacturing QA DS Pharma, DP and Head of GMP/GSP Quality Operations, or VQLs in times of absenteeism (e.g., vacation, illness)
- Resolve quality disputes with the strategic vendors through negotiations and persuasion
- Represent UCB Senior Quality Assurance management at meetings with senior management of the vendors
- Oversee QA participation on the regular vendor meetings, to present issues and resolutions, and drive vendor quality performance through these meetings
- Promote Best Practices throughout the GMP/GSP Quality Operations team
- Organizes regular face to face meetings with the person’s direct reports, holds personal development discussions and agrees on a personal development plan with his direct reports. Performs at regular intervals employee’s performance evaluations and drives an active feedback culture within the organization
Leading the Inspection Readiness for GMP/GSP Quality Operations:
- Own, improve and oversee the process for the preparation of GMP/GSP Quality Operations to ensure constant Inspection Readiness
- Lead, manage and motivate the Inspection Readiness Quality Support function
- Ensure Key Performance Indicators are defined and closely monitored
- Manage
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