Head of External Manufacturing Quality Operations Bio DS

工作内容

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 Assuranceteam, 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 AccountabilitiesLeading 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 and escalate risks linked to Inspection Readiness

Leading The Quality Oversight Of External Network Governance (ENG)

• Collaborate closely as Quality representative with the Head of External Network Governance (ENG), part of the External Manufacturing Leadership Team. ENG is owning all processes (selection, operations, risk, phase-out) related to UCB GMP/GDP Vendor management.
• Represent Quality in ENG Process improvement projects, or ensure proper delegation within the GMP/GSP Quality Ops team.
• Present ENG processes during UCB inspections and/or partner audits together with the Head of ENG
• Represent Quality in the Outsourced Manufacturing Committee, to ensure new or changes in the vendors network are properly assessed together with other DMSO Leaders
• Deputy of the Head of GMP/GSP Quality Ops in the Sourcing Committee, where Make or Buy decisions are made with Sr. Management of DMSO

Leading The External Manufacturing Operations Leadership Team (EMOLT)

• Lead the cross-functional team with the mission to keep Consistency of External Manufacturing Operations practices across the board
• Lead the yearly objective setting of the EMOLT, and track progress and completion
• Ensure the EMOLT is connected with other Governance bodies in DMSO like ENG Governance, Focus Area LTs, External Manufacturing LT
• Drive the change, build the community of Best Practices across the External Manufacturing portfolio
• Steer the external manufacturing community to ensure compliance and efficiency

Interested? For this position you’ll need the following education, experience andskills:Technical Capabilities

• Master’s degree
• Minimum of 10 years working in the pharmaceutical/biologics industry in a quality management position. Operational GMP experience would be a distinct advantage
• Experience in interaction with regulatory bodies and third-party organizations with respect to QA systems and regulatory inspection preparedness.
• Experience in people management, driving Personal Development plans and motivating a team of professionals is an important asset

Competencies

• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective. Experience in Biologics would be a distinct advantage
• Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
• Be capable of leading and motivating teams with a substantial amount of autonomy and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
• Able to generate enthusiasm and commitment to strategic priorities
• Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters
• Must have the ability to manage projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results
• Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels
• Must have strong process improvement and risk management skills
• Generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental/company vision
• Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent
• Must be skilled and experienced in operating across cultures and in a multi-cultural environment

Fluent in EnglishWhy you should applyAt UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration, and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.About Us.UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.Curious to know more? Please visit our website www.ucb.com .UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.