Job Description
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Senior Specialist – External Quality Vaccines acts as Product Quality Manager (PQM), responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements. The role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners (EP/ExP’s) manufacture and release of vaccine drug substance and drug products by means of risk-based quality oversight and on-site supervision, as appropriate.
They will support partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported, production volumes, number and complexity of in-markets, historical performance (production and compliance), new product or market launches, historical relationship between our company and the partner, manufacturing process complexity. This position will report to the Quality Director or Associate Director, External Quality, for general advice and instruction concerning project, but functions independently. The position is based in Europe.

QUALIFICATIONS AND EXPERIENCE:

• Educational background in a relevant discipline
• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
• Solves complex problems; takes a new perspective using existing solutions
• Works independently with minimal guidance
• Acts as a resource for colleagues with less experience within own discipline; can provide guidance on issue resolution and act as SME
• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others
• Explains difficult issues and works to build alignment around a complex situation
• Accountable for a medium project with minimal resource requirements, risk and/or complexity
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
• Communicates easily in English both verbally and in writing
• Strong knowledge of External Manufacturing management, supply chain, and operations, preferably direct experience with managing external partners

PREFERRED EXPERIENCE AND SKILLS:

• Additional languages (French, German, Italian) are an asset
• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience
• Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs)
• Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ)
• Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards
• Quality Risk Management (QRM) Experience
• Lean Six Sigma / our Production Systems training

TRAVEL REQUIREMENTS:

25%

• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations
• Review and approve changes to master batch records
• Manage routine and complex deviations and complaints and assist in the coordination of significant investigations including Fact Findings
• Assist in the coordination of any product recall involving the external manufacturer
• Provide support for audits of EP/ExP by ourselves and regulatory agencies
• Review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
• Conduct routine and solve complex analytical change requests and support process modification change controls
• Stability Program management, including review of stability reports, and Annual Product Review assembly
• Provide on-site guidance in the preparation of metrics, procedures, and guidelines
• Provide proactive support in training and coaching to initiate quality improvements
• Track and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plans
• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration
• Responsible for shipment under quarantine
• Support routine process validation; review and approve validation reports/tech transfer
• Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes
• Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums