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Glob Quality Ld GMP Auditing&Compliance

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  67234

 Global GMP Quality Assurance Auditing & 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 Braine l’Alleud, Belgium, we are looking to fill the position of: Global GMP Quality Assurance Auditing & Compliance

 

Reporting directly to the Head of Global Quality - Auditing and Compliance, the incumbent ensures that UCB’s development, manufacturing, testing and distribution activities are compliant with the latest regulatory standards and internal policies.

Additionally, is responsible for identifying and ensuring that compliance risks are appropriately identified and mitigated.

These goals are achieved via the effective execution of internal and external global auditing, setting internal quality standards and policies, keeping abreast of global regulatory and industry trends, as well as by consulting and educating in-house. 

This position requires a high level of communication and organization in-order to properly identify gaps and compliance risks across the UCB network and gain alignment with stakeholders and Sr. Management as to the understanding on the severity of the potential associated risks. 

 

As a UCB GMP Auditor, you will contribute by:

 

Internal & External Auditing:

  • Support the creation and maintenance of the Global Audit Program, leveraging a risk-based approach for ranking and prioritization,
  • Support the Global Audit Program through the execution of Due Diligence Audits, Mock Inspections, Routine GMP, For Cause audits and Pre-approval or Routine inspection assistance as assigned per senior management,
  • Ensure the follow up on the above-mentioned audits or inspections, as well as timely CAPA closure,
  • Support the development and execution of the Auditor Qualification Program

 

GMP and GDP Quality Systems:

  • Take ownership as Process Owner(s) of one core and/or several ancillary Quality Systems,
  • Act as the UCB Subject Matter Expert and global resource for these systems,
  • Create and own the supporting UCB Policies and standards,
  • Oversee their deployment including training material development, periodic review by senior management, as well as their maintenance by leveraging the Regulatory Surveillance process and industry benchmarking.

 

Consulting, Educating and External Focus:

  • Act as an in-house Consultant and Educator to ensure that the UCB network remains up-to-date with regard to regulatory and industry trends,
  • Provide Technical and Compliance guidance as a member of selected committees,
  • Lead improvement initiatives, identified by senior management, in-order to improve Corporate QA processes and effectiveness,
  • Partner 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,
  • Keep abreast of regulatory and industry trends:  Share key information gathered via professional associations and regulators (upcoming regulations, best practices) across the UCB network and ensure they feed into Quality Standards.

 

Compliance Issues:

  • Partner with colleagues/others to identify and mitigate Compliance risks, resolve potential regulatory observations,
  • Escalate critical Compliance risks to upper management.
  • Leverage 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 (depending on region) science related field

Certification (Describe): Certified Auditor or Quality Professional (e.g. ASQ) – Preferred but not required  

Registration (Describe): Industrial Pharmacist – Preferred

 

  • Educated to a Masters level in a relevant scientific discipline (Pharmaceutical, Bio-Engineering, Microbiological or related science)
  • 10 years’ experience minimum in a Quality Assurance role, dealing with Biopharmaceuticals/Advanced Therapies 
  • Profound expertise within Drug Substance and/or Drug Product manufacturing of pharma/biopharma drugs
  • Combination Product and Device QMS and regulatory knowledge/experience preferred
  • Extensive Audit experience as Auditor or Auditee
  • Experience with preparation and/or facilitation of regulatory inspections (FDA, ANVISA, KFDA, EMA, … ) is a strong asset
  • Fluent in English both speaking & writing (additional languages advantageous)
  • Good knowledge of Trackwise
  • Excellent presentation and training skills
  • Proven analytical and investigation skills

 

 

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. 

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