Senior Director of Quality

The Site Quality Leader owns the Quality function, including Quality Assurance and Quality Control, at the Speke Manufacturing operation.  The incumbent will be responsible for directing the efforts of an overall Quality organization of roughly 50 personnel.

Reporting to the SMN Global Quality Leader, with dotted-line reporting to the Site Head, the Site Quality Leader is responsible for providing technical, regulatory/compliance, and strategic leadership for the Quality function at Speke.

The Site Quality Leader role is accountable for all Product Quality, Compliance and Quality Systems activities for all commercial products at the site.  Additionally, this role is accountable for development, launch and commercialization of new products in collaboration with Elanco R&D and other relevant functions.  This role is a core member of the Speke site leadership team who collectively steer the business mission of the site.

The role is integrated within the wider network Quality leadership team, which sets the Quality strategy for the function across Elanco.

• Ensures all aspects of Quality Management for applicable regulatory bodies are carried out according to the standards defined and are regularly reported and assessed for adequacy of performance.
• Manage/support the resolution of quality and technical problems in alignment with global standards
• Ensure that  all-critical and major issues, which may have an adverse effect on the quality of the product, are escalated as per standard procedures to management and are resolved within stated timelines.
• Responsible for notifying the Veterinary Medicines Directorate (VMD) Rapid Alert network (rapidalert@vmd.gov.uk) immediately upon discovering or suspecting a product defect that could compromise the safety, quality, or efficacy of a batch.
• Support Development of the Quality Strategy and the Quality Planning. Develop Site/Hub Quality Plans. Track implementation, maintenance and review of these Q plans
• Assess and drive readiness for HA inspections (PAI, directed, other)
• Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned
• Prepare and manage organizational Quality budget
• Provides oversight and resourcing where applicable within the organization for projects (transfers, launches, due-diligence, other) – providing support where needed to ensure compliance with the Elanco Q System, and to facilitate issues escalation and resolution.
• Assure appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals. Initiate corrective actions when necessary and perform follow-up on resulting measures.
• Support deployment of operational excellence strategies to drive lab and site wide productivity.
• Work closely with Manufacturing and Supply Chain partners to assure business and quality objectives are achieved at sites and that a business partnership culture is maintained with Q and other cross-functional partners.
• Recruit and develop global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning. Develop a high-performance culture
• Work with staff to define development goals and succession plans for direct reports and critical roles. Build and maintain a robust talent pipeline within the Quality organization.
• Deploys Quality Risk Management Techniques for quality oversight and problem resolution.
• Mitigates unacceptable risk in conjunction with Elanco Manufacturing/Supply management and Quality.
• Ensures the Quality Assurance Agreements for Suppliers are created and maintained according to Elanco requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product.
• Support deployment of operational excellence strategies to drive lab and site wide productivity

• The leadership competencies critical to this role include:
  • Drives Engagement
  • Instills Trust
  • Manages Complexity
  • Plans and Aligns
  • Drives Results
  • Builds Effective Teams
  • Leadership through Transformation
  • Drives Digital RoadMap

• BS in a scientific field
• Demonstrated change, people & technical leadership experience in both the manufacturing and quality functions – ideally at both a site & network level
• Demonstrated experience in the pharmaceutical industry, with direct experience with Pharmaceutical/API products. Experience in QA Operations, Manufacturing, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 10 years of management and or project management experience.
• Thorough knowledge of global cGMP requirements.
• Strong understanding of regulatory requirements for commercial global DP processes
• Proven track record with inspection management VMD, FDA and others
• Strong understanding of risk assessment and risk management fundamentals/tools

• Technical understanding of DP manufacturing/testing processes
• Familiarity with Large Scale Fermentation
• Problem solving skills and the ability to deal with ambiguity

• Travel: 0-10%
• Location: Speke, UK
  

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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