Make your mark for patients
We are looking for a Head of Quality Auditing GMP / GDP who leads with courage, drives change, and communicates clearly to join us in our Global Quality team, based in or close to our Atlanta, GA or Raleigh, NC office in the United States. We are a hybrid workforce.
About the role:
This is a key leadership position responsible for ensuring Good Manufacturing and Distribution Practices (GMP/GDP) adherence within our Pharmaceutical, Biological and Gene Therapy organizations throughout the development and commercial product lifecycle.
This role involves design, strategic planning, delivery, and mitigation of the risk-based audit program across all territories where UCB is present or operations through third parties. The scope also includes continuous improvement initiatives.
Who you'll work with:
The Head of Quality Auditing and Compliance Good Manufacturing and Distribution Practices reports to the Global Head of Quality Auditing & Compliance and works collaboratively with internal stakeholders (e.g., Supply and Technical Solutions, other Units within Quality, etc.) for internal/external audit universe definition, strategy, and risk assessment.
The qualified candidate will lead and develop an international quality auditing team of GMG auditors and overseas strategic and tactical auditing partnerships.
What you'll do:
- This role involves design, strategic planning, delivery, and mitigation of the risk-based audit program across all territories where UCB is present or operates through third parties, as well as continuous improvement initiatives.
- Leads and develops an international quality auditing team.
- Oversees strategic and tactical auditing partnerships.
- Plays key role for mission critical Health Authority Inspections by Regulators.
- Translates Regulation Intelligence and Inspection Intelligence into audit strategy & program.
- Actively Participates in Industry Associations and cultivates an external network.
- Promotes strong collaborative partnerships with key internal stakeholders.
Interested? For this role we're looking for the following education, experience, and skills:
- Master's Degree in a Life Sciences and/or Engineering/Statistics/Data Science specialty.
- Previous international leadership and management experience (15+ years) in the Biopharmaceutical industry within regulated areas (e.g., Manufacturing) and/or Quality Assurance expertise.
- In depth knowledge and understanding of the complexity of the BioPharma business, including drug development process and post-marketing obligations, GXP principles and digital trends.
- Strong business acumen and previous experience and/or certification as an auditor.
- Previous experience interfacing with Inspectors for mission critical inspections (e.g., US FDA, etc.).
Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.
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.
Requisition ID: 86046
Recruiter: Chris Venegas
Hiring Manager: Helen C. Motamen
Talent Partner: Sandrine Eelbo
Job Level: SM I