Overview

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

The Head of Quality Control is responsible for establishing the new Quality Control (QC) laboratories and staffing as well as developing and leading QC laboratory operations at the new Holly Springs site.

As Head of QC, you will have a key role to create and implement the QC strategy for our new facility, collaborating closely with the Holly Springs Head of Quality and our siter site in Denmark to ensure alignment and consistency. You will be accountable for delivery of all QC programs, projects and laboratory operations, ensuring staff remain on task and execution is aligned with internal/external customer expectations, regulatory expectations and with industry best practices.

External US

Responsibilities:

• Develop and implement strategy and roadmap for Quality Control at the Holly Springs site
• Establish the new QC laboratories capabilities to meet the needs of the new Holly Springs site.
• Build and lead QC Team with intention, providing clear priorities, feedback and career development opportunities
• Oversee all of Quality Control operations, including QC Raw Materials, In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, the Environmental and Utility Monitoring program and administration of the Stability Programs
• Coordinate and harmonize activities and policies between site departments and across other FDB sites
• Manage QC department budget, timelines and schedules
• Provide direction to project teams, identifying issues of concern and providing solutions
• Assure that all areas of responsibility are cGMP compliant and audit-ready
• Oversee the development and implementation of standards, methods and procedures for testing and evaluating the quality and safety of products
• Manage technology transfers and method improvements needed to assure reliable, robust, fit for purpose, and cGMP compliant methods available for the laboratories
• Manage a QC Lab to tight timelines, providing reliable analytical results in a highly regulated environment
• Support and participate in client visits, audits and regulatory agency inspections
• Establish and meet department schedules and performance requirements
• Interact and meet regularly with cross-functional leaders on matters concerning their functional areas, groups or clients
• Ensure that QC employees comply with required safety and cGMP procedures and protocols, and that they attend and participate in required trainings

Requirements:

• Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related field is required. MS or PhD preferred
• Prior Lean Six Sigma experience and/or certification
• 10 years’ experience in Quality Control within the Pharmaceutical / Biotechnology Industry
• 7 years’ leadership experience
• Prior experience working with biological products
• Experience leading client site visits, audits and regulatory inspections
• Strong orientation for quality, compliance, business ethics and customer service
• High level of integrity and a drive for continuous improvement
• Strong collaboration and team building skills
• Ability to motivate, lead and develop subordinates
• Prior experience managing in a matrix organization and collaborating at a global level