Loading...
Share this Job
Apply now »

 

Let's push the boundaries together and make the most of your talents!

Glob Quality Lead Digital Compliance

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  68798

Global Quality Lead Digital Compliance

 

Help us transform patients' lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases.  Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure? 

To strengthen our Global Quality Assurance department, based in our hub in Braine l’Alleud, we are looking for a talented individual to fill the position of: Global Quality Lead Digital Compliance

 

As a UCB Global Quality Lead Digital Compliance, you like to work in an environment where you can:  

 

  • Co-create a strategy, including defining the internal/external Digital universe for UCB across GxP (e.g. GCP, GDP, GLP, GMP, GVP, Good Scientific Practice, …)  in collaboration with IT, other key business stakeholders, and Quality. 
  • Co-develop risk assessment of the digital universe and contributes to auditing of the prioritized GxP Targets and mitigating issues that are identified. 
  • Ensure that UCB’s digital/computerized systems and IT infrastructure associated with GxP activities are compliant with the latest and evolving regulatory standards and internal policies.

 

The goal will be achieved by developing a comprehensive understanding of Digital impact on UCB business ecosystems in order to propose digital risk mitigation program.  This mitigation program is comprised of internal and external auditing, implementation of internal quality standards, policies and KPIs, keeping abreast of global regulatory and industry trends, as well as by consulting and educating in-house Quality personnel

 

As a UCB Global Quality Lead Digital Compliance, you will contribute by:

 

Internal & External Auditing:

  • Setting definition and direction around the evolving Digital Universe relevant for GxP areas.
  • Supporting the creation and maintenance of the Global Audit Programs, leveraging a risk-based approach for ranking and prioritization.
  • Supporting the Global Audit Programs through the execution of Due Diligence Audits, Mock Inspections, For Cause audits and Pre-approval or Routine inspection assistance as assigned per senior management including but not limited to Commercial and Development Software, Data Mgt, Web Based Applications, Mobile Apps, Devices, etc.
  • Ensuring the follow up on the above-mentioned audits or inspections, as well as timely CAPA closure.
  • Identifying, selecting and overseeing external resource (e.g. consultant and/or vendor) to help with peaks of work so UCB has more bandwidth if/when needed.

 

Computerized System Validation (CSV) Quality Management Systems:

  • Taking ownership as Corporate Process Owner(s) of CSV and ancillary Quality Systems.
  • Acting as the UCB Subject Matter Expert and global resource for these systems.
  • Owning the supporting UCB Policies and standards and overseeing their deployment and update including training material development, periodic review by senior management, development of associated KPIs, as well as their maintenance by leveraging the Regulatory Surveillance process and industry benchmarking.
  • Collaborating with other stakeholders within UCB to establish Quality Standards in UCB beyond CSV (e.g. artificial intelligence, etc.).

 

Consulting, Educating and External Focus:

  • Acting as an in-house Consultant and Educator to ensure that the UCB network remains up to date about regulatory and industry trends.
  • Providing Technical and Compliance guidance as a member of selected committees.
  • Partnering with the UCB Network QA operational teams to prepare sites for pre-approval and/or routine regulatory inspections, as deemed necessary and which may include on-site or remote inspectional support activities.
  • Keeping abreast of regulatory and industry trends:  Sharing key information gathered via professional associations and regulators (upcoming regulations, best practices) across the UCB network and ensure they feed into Quality Standards.
  • Participating in Global Industry Association(s) as UCB representative to contribute to standard setting and benchmarking use of new technologies.
  • Building the data & digital competency for the UCB auditors across GxP disciplines.

 

 Compliance Issues:

  • Partnering with colleagues/others to identify and mitigate Compliance risks, resolve potential regulatory observations,
  • Escalating critical Compliance risks to upper management.
  • Leveraging internal resources and SME network to develop appropriate action plans and decisions as needed.

 

 

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

  • Master’s degree in a relevant discipline (Computer Science, Pharmaceutical, Biomedical-Engineering, Microbiological, Data Science, or related science)
  • Certification (Describe): Certification in Information Systems is desirable but not mandatory.
    • CISA – Certified Information Systems Auditor
    • CISSP – Certified Information Systems Security Professional
  • 2 to 5 years of experience minimum in a Quality role and overall 10+ years, dealing with Computerized Systems Validation, Data Integrity, Software, Hardware, Apps, etc.., within Biopharmaceuticals /Advanced Therapies.
  • Additional experience (non-Quality) with methodologies and practices within Software Development and Infrastructure Design is a plus.
  • Solid knowledge of regulatory requirements and guidance associated with electronic systems and data management including but not limited to GAMP 5, 21CFRPart11, OECD, Eudralex Vol 4., annex 11, PIC/S, IEC62304 – Int’l std for medical device software, – Clinical, FDA Guidance on Computerized Systems used in Clinical Studies.
  • Helpful to have knowledge of EU guidance on Good Pharmacovigilance Practices and/or ICH E6(R2).
  • Familiarity with Drug Substance and/or Drug Product manufacturing, testing, distribution of pharma/biopharma drugs including clinical and pharmacovigilance programs, Combination Product and Device QMS and regulatory knowledge/experience preferred
  • Previous Audit experience as Auditor or Auditee is preferred.
  • Knowledge in and experience with application of regulatory requirements associated with the qualification, validation, implementation, use and life-cycle management of digital systems, tools and applications within a Biopharmaceutical/Advanced Therapies environment.
  • Analytical mind-set to understand complex Compliance and Regulatory issues associated with digital systems.
  • Excellent presentation, training skills, interpersonal, negotiation, planning, and organizational skills.
  • Able to prioritize according to Compliance and Patient Safety risk.
  • Ability to build partnerships internally and externally.
  • Ability to communicate clearly (both orally and in writing) to UCB sites, partners and vendors.
  • Ability to present complex projects and issues to senior management in a clear succinct manner.
  • Management of Transversal and Process improvement projects.
  • Communicating fluently in English both speaking & in writing (additional languages advantageous).
  • Statistical knowledge (or knowledge of statistical principles) would be helpful.
  • Programming knowledge or familiarity (e.g. COGNOS, Qlik, R, etc.) would be helpful.
  • Experience with Audit Management Tools, Controlled Document Management Systems, Regulated Databases (e.g. Clinical, Safety, etc.) advantageous.
  • Fluent in Business and Cloud collaboration tools.
  • Familiar with ERP / CRM Business Enterprise tools (e.g. SAP, Salesforce, etc.).
  • Familiarity with current trends with various cloud platform technologies (e.g. AWS, etc.).

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

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. 

Apply now »