External Manufacturing and Supply – Specialty Care Large Molecule Site Operations Lead

Bachelor’s degree with scientific background or equivalent and 12+ years of experience
Master’s degree with scientific background or equivalent and 8+ years of experience
Strong prior experience in operational roles, ideally within Pharmaceutical or Biotech Vaccines arena
Strong quality mindset
Knowledgeable in support quality investigations
Experience with operational excellence and continuous improvement initiatives

Work in partnership with the External Manufacturing Site team and Specialty Care Functional Leadership
Ensure on time & in full delivery of products for CMOs/External Suppliers
Accountable to understand the products as it is implemented at the CMOs from an operational & financial perspective
Build collaborative business relationships with external partners
Serve as the first level of escalation to the External Manufacturing Product Teams
Actively participate in CMO driven Joint Steering Committee (JSC) meetings
Escalate issues to appropriate forums, as needed
Accountable to understand the contract guidelines and the impact to the product/departmental P&L of production variations
Responsible for implementing Life Cycle management projects
Responsible for the adherence to the Risk Management Program
Ensure Compliance through active participation at all applicable quality governance forums
Accountable for reviewing and providing technical of critical deviations
Accountable for on time Quality System related records
Interface with external regulatory authorities as required
Work with EST, EMPT leads and Functional heads for standardization of processes and procedures