Global Quality Lead/Associate Director GMP Auditing&Compliance

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Date: May 14, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Global Quality Lead/Associate Director GMP Auditing&Compliance

Quality Assurance

 

Location: Braine l`Alleud

 

Help us transform patients’ lives.

 

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

To strengthen our Global Quality Department, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of:

 

Global Quality Lead/Associate Director GMP Auditing&Compliance.

 

Do you have an agile mind that enjoys being analytical? For UCB, you are an ‘agilytical’ person. This innovative blend of talent means you are able to swiftly apply forward thinking for the good of patients.

As a UCB 'agilytical' person and Global Quality Lead GMP Auditing and Compliance you like to work in an environment where you can:

 

  •  Interact with a wide range of stakeholders and senior managers
  • Identify gaps and compliance risks across the UCB network and gain alignment with stakeholders as to the understanding on the severity of the potential associated risks.
  • Travel the globe 30 to 35% of the time

 

As a UCB 'agilytical' person and Global Quality Lead/Associate Director GMP Auditing&Compliance you will contribute by:

 

Internal & External Auditing:

  • Providing expert consultation and experiential assessments on the state of the global supply chain network through the creation and maintenance of the Global Audit Program, leveraging a risk-based approach for ranking and prioritization,
  • Leading audit teams and stakeholders in the Global Audit Program through the timely execution of due diligence audits, mock inspections, routine GMP, for-cause audits and pre-approval or routine inspection assistance.
  • Partnering with stakeholders to contribute to mitigation of the Compliance, Regulatory and Quality risks through the follow up on the above-mentioned audits or inspections, confirmation of appropriate CAPA as well as timely implementation and closure,
  • Provide Couceling and Education of internal colleagues related to the development and execution of the Auditor Qualification Program

 

GMP and GDP Quality Systems:

  • Take ownership as process owner 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,
  • dealize, Promote and Lead improvement initiatives 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: Interpret and Share key insights and information gathered via professional associations and regulators (upcoming regulations, best practices) across the UCB network and ensure they feed into Quality and Ops Standards as appropriate.

 

Compliance Issues:

 

  • Partner with colleagues/others to identify and mitigate Compliance risks, resolve potential regulatory observations,
  • Escalate to Sr. Management and assist in development of strategies to remediate critical Compliance risks.
  • 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:

 

  • Profound expertise within Drug Substance and/or Drug Product manufacturing, testing and distribution of pharma/biopharma drugs including global GMP/GDP regulatory requirements. (Some experience preferred with Medical Device and/or Combination Products)
  • 10 years’ experience minimum in a Quality Assurance role (Preferred 15+ yrs).
  • 5 years’ + experience in auditing.
  • Experience with preparation and/or facilitation of regulatory inspections (FDA, ANVISA, KFDA, EMA).
  • Excellent communication skills in English to present complex projects to senior management and build partnerships internally and externally
  • A strong analytical mind-set to understand global, complex Compliance and Regulatory issues
  • Negotiation skills and a proven ability to influence others within a global matrix organisation

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.


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