CMC Development Quality Lead

JOB DESCRIPTION

Make your mark for patients

To strengthen our Global Quality Assurance department, we are looking for a talented profile to fill the position of: CMC Development Quality Lead – Braine l’Alleud, Belgium

About the role

As part of the CMC Quality Management organization, specifically within the CMC Development Quality group, you will lead strategic quality management across CMC Development Sciences groups in their product and process development activities, adhering to ICH guidelines.

This profile will ensure that quality and compliance issues are managed with diligence, rigor, and transparency in all CMC activities. This includes supporting product and process development, clinical supply manufacturing, analytical work, technology transfer, CMC filing, and more, from early phases to the commercial launch of the product. The goal is to ensure product quality and compliance with regulatory requirements, while meeting business performance expectations.

You will work with

To ensure effective QA leadership for their product development projects, the CMC Development Quality Lead will closely collaborate in a lean, efficient, and trustworthy manner with all functions involved in CMC and GMP strategic activities throughout the lifecycle management of global pharmaceutical and biological products. This collaboration aims to ensure the development of high-quality, safe, and efficacious products. Additionally, there will be a collaboration with other global QA functions, including GMP/GSP Quality Operations, to manage the operational aspects of clinical and development batch manufacturing.

What you will do

• From early development stages up to Proof of Concept (PoC) included:
• Proactively provide guidance and advice to CMC Development Sciences Project Technical Solution Team (Project TST) representative members, particularly with regard to the appropriate use of UCB Quality by Design (QbD) guidelines, and interpretation of national and international cGMP regulations and ICH guidelines
• Ensure that CMC project related Quality Assurance activities are consistent across the range of different environments and teams supported (Vendors & Strategic Suppliers / UCB in house manufacturing / UCB Partners …)
• Review and approve adequate documentation made available and followed for CMC development projects (Process & manufacturing descriptions / Specifications / Justification of specifications / Analytical methods / Change controls / Validation protocols, Deviation impacting product & process control strategy, including Out of specification and Out of trends) for all CMC and clinical supply related activities
• Responsible for leading participation in partnerships with other departments to identify, mitigate and subsequently resolve compliance and quality issues that may affect UCB development activities and products. These lessons learned once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities
• Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions
• Partner with project teams to address operational deficiencies identified by regulatory Agencies.
• Actively participate in identifying, developing and implementing local 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, developing solutions, guidance and procedure.
• For product late-stage development up to commercial launch:
• Ensure quality oversight on TST decisions that frame-up CMC strategy and documentation package for late-stage development: Technology transfer, product and process control strategy, process comparability between small and large scale manufacturing, process characterization, process validation, validation of analytical methods, product characterization, product stability, and pre-approval inspection readiness
• Coordination of and oversight on the Quality Assurance group members responsible for QA review and approval of late-stage development documents
• Ensure progressive transfer of product and process control strategy documents to CMC Quality Lead who will ensure accountability of product quality oversight in the commercial phase
• Organize and directly contribute to Quality Assurance review of CMC file (development sections) prior to submission to health authorities
• Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions
• Partner with project teams to address operational deficiencies identified by regulatory Agencies
• Ensure that all operations are appropriately compliant with applicable regulations (EMA, FDA, DEA, MHRA, OSHA, DEC, etc. where relevant). As CMC Development Quality Lead, support preparations for any pre-approval internal/external audit in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Formulation Development, Process Development, Process Support, and Package Development practices (where relevant)

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

• Bachelor’s or Master’s degree in a relevant scientific discipline
• Minimum of 5-8 years experience in the sector with a good knowledge of cGMP and product development regulatory requirements (eg US, European, Japanese)
• Fluent in English communication (oral and written); any additional languages are a plus
• Possess exceptional interpersonal skills, enabling effective communication and collaboration with diverse teams and excel in delivering clear and compelling presentations
• Capable of working independently with minimal supervision, showcasing a high degree of self-motivation and initiative
• Be able to maintain a proven track record of successful teamwork, consistently contributing to collaborative efforts and fostering a positive team environment
• To exhibit solid project management skills, adept at planning, organizing, and overseeing projects from inception to completion
• To demonstrate strong organizational skills, with the ability to manage multiple tasks and priorities effectively
• Possesses excellent analytical skills, enabling thorough evaluation of data and informed decision-making
• Fact-based decision maker: Capable of understanding complex issues and contributing to informed decision-making, particularly when dealing with ambiguous or “grey” areas
• Identify potential risks and proactively propose corrective actions to mitigate these risks, ensuring the stability and reliability of operations
• Embrace “outside-in” principles to remain attuned to industry trends and best practices, integrating external insights to enhance internal processes and strategies.
• You must be familiar with requirements set forth in various regulations effective for the manufacturing of clinical supplies and development of new product (Note: Non exhaustive list):
• In Europe
• EU Clinical Trial New Regulation 536/2014 (EU-CTR)
• Principles of good Manufacturing Practices as required in Directive 2003/94/EC
• Article 13.3 of Directive 2001/20/EC related to the manufacturer or importer of medicinal products
• The related Product Specification File (PSF) resp. Article 9.2 of Directive 2001/20/EC and EU GMP Annex 13 rev 1 article 40, e.g. batch records incl. control reports, examination of finished products, audit reports, stability reports, etc.
• In US :
• cGMPs 21 cfr part 211, 600;
• FDA Guidance for Process Validation, FDA Guidance for Out of Specification,
• FDA Guidance for PAI 7346.832 – Pre-approval Inspections (Revision 16/09/2019)
• ICH guidelines, mainly ICH Q1, Q2, Q3, Q5, Q6, Q8, Q9, Q10, Q11 & Q12

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! 

About us 

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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