QA Officer Drug Substance

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Internal Manufacturing department, based in our Belgian site of Braine-l’Alleud, Belgium, we are looking for a talented individual to fill the position of QA OFFICER Drug Substance.

As QA OFFICER Drug Substance, you will work in an environment where you can:

• Together with appropriate management, responsible for the implementation and maintenance of an effective Quality Management System on the UCB Braine Site.
• Assure that all technical operations related to the manufacturing of pharmaceutical products (DS) comply with applicable national and/or international regulations and guidelines (GMP) & relevant UCB Quality Policies.
• Assure that marketed pharmaceutical Products are manufactured and supplied in accordance with UCB Product Quality Standards.
• Pro-actively help operations to identify, develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements
• Drive continuous improvement projects that will allow risk reduction, improvement KPI and product quality

You will contribute by:

BACK-UP FUNCTION

• The position can act as back-up for his direct colleagues or for the Associate Director QA Chemical manufacturing according to the Associate Director’s instructions and after appropriate training

OPERATIONAL QA ROLE

• Assure that intermediates and active pharmaceuticals products get produced and released in accordance with UCB Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
• Follow up of product related

• • Change control
  • Failure investigation
  • Deviations (planned and unplanned)
  • Qualification of dedicated equipment (protocols and reports)
  • Cleaning validation of dedicated equipment
  • Process validation (protocols and reports)
  • Stabilities (protocols and reports)
  • CAPA and action plans

• 
  Review of batch record from intermediates to drug substance
• Batch disposition of chemical intermediates (DS manufacturing)
• Review of master batch records and specifications
• Writing and follow up of Product Quality Review
• Follow up of RA commitments
• Authorization of technical transfer towards manufacturing (protocol and report)
• Authorization of re-tests for chemical substances (DS manufacturing)

CONTINUOUS IMPROVEMENT

• Support the BTO Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations
• Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the Braine site.
• Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
• Using a Risk Based Approach, ensure that all BTO Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures hereby considering UCB objectives, plans and projects
• Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BTO and related supporting services
• Ensure general cGMP training of internal customers
• Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements
• Ensure communication of compliance status and issues to appropriate levels of the organization
• Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BTO and related supporting services
• Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections

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

Education

• Master’s degree required.

Experience

• Minimum of 5 years in a regulated pharmaceutical environment or other life science or health related field, including experience in Quality Assurance or Quality Control.
• Experience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry.
• Experience with Quality Management System and Internal/External Auditing.

Skills

• Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision
• Fact based decision maker with accountability and delivering attitude
• Excellent team player attitude with excellent interpersonal relationship and communication skills
• Excellent oral and written communication skills
• Excellent organization & coordination skills
• Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
• Independently identify problem situations, communicate appropriately and initiate problem-solving process
• Ability to influence by persuasion
• Good project management skills
• Stress resistant
• Ability to make quality/compliance decisions in a business environment.
• Fluent in French (Braine working language) and English (contact with global level, customers and authorities)
• Ability to lead (small) project teams and to motivate & inspire internal customers
• Capable of independently resolve conflict situations
• Independently identify, communicate and initiate problem solving process, search for pragmatic solutions

Why you should apply?

At 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.

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.