Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare Other Science and Tech
3 - 5 Years
Release & Stability Manager QC
The Leiden Quality Control (QC) Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site belonging to the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site.
Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing.
The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise. All test laboratories are supported by the Release & Stability team, which is integrated by product E2E QC owners who lead and coordinate the release and stability testing processes for commercial products through deep expertise and effective communication between global stakeholders (e.g. DPDS, PQM, VPAD, VCM, CMOs, EQ) and Leiden QC.
The Release & Stability team leads and supports complex non-conformances investigations, initiates improvements to optimize the testing strategy and execution, and owns the Life Cycle Management activities for the commercial products tested at Leiden QC.
Goal of the function/Primary objective of the Job
Responsible for managing and coordinating the Stability & Release team, which is composed of several experts and scientists engaged in commercial products Life Cycle Management, issues management and resolution, and several improvements projects.
Supervisor: Sr Manager Stability, NPI and New Technologies
Direct reports: 6-8 Scientist/Experts plus contractors
Tasks and Responsibilities
Technical and job specific
Ensures release and stability testing processes are robust and standard to ensure compliant, efficient and on-time testing.
Secures budget and resources for commercial products support for the department.
Supports the department with being an expert on stability and E2E release testing of JSC Large Molecules
Coordinates the release of raw materials, drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines.
Coordinates the stability testing of JSC large molecule products according local procedures and agreed timelines.
Proactively partners with stakeholders to position the Leiden QC department as large molecule stability hub and CMO release testing for commercial products.
Manages Life Cycle Management projects and requests for commercial products.
Ensure the team is subject matter expert on release and stability processes and has a leading role during the GMP inspections and throughout the LCM of the commercial products
Maintains oversights over the implementation of guidelines, regulations and global standards related to stability management and execution.
Reviews stability protocols, release Certificate of Analysis and Quality Agreements/ SLAs with multiple customers.
Participate in management meetings, joins the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM, External Quality) and other testing sites to ensure flawless experience and network alignment
Represents Leiden QC in escalation and senior management platforms in relation to release or stability testing escalations, strategy, and improvements
Mentors, coaches, trains, and develops the personnel of the team. Evaluates performance and provides opportunities for growth.
Manages the planning and resource allocations of the team
Manages the development and implementation of metrics to measure and improve performance
Secures resources and budget for commercial release and stability testing within Leiden QC
Creates a team environment for continuous improvements and critical and creative thinking
Compliance, Quality, Safety and Health
Ensure that procedures and guidelines linked to safety and health are met
Ensure that the group complies with the environmental procedures and guidelines
Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.
Ensure that data are generated and maintained according to current regulatory requirements
Job interaction areas
Internal: functional departments within the Quality organization, Value Chain Teams, regulatory compliance group, R&D (DPDS, VPAD), Product Quality Management PQM), External Quality, Quality Assurance (QA), Business Units, manufacturing sites within JSC, Global Planning.
External: contract labs, CMOs
Profile needed for this function
Education / Qualification
Master degree in chemistry & biotechnology or equivalent by experience with 8-10 years’ experience in the pharmaceutical industry.
Experience in Quality Control, Method development, validation, etc.
Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.)
General knowledge of pharmaceutical development & manufacturing
Experience in other supply chain functions is an asset (e.g. Operations, Quality, Planning)
Organizational planning and problem-solving experience
Strong leadership & development qualities
Experience with principles of Process Excellence, Lean manufacturing, etc.
Good presentation skills
Excellent knowledge of English
Experience in managing people (direct report lines, or indirect e.g. projects)
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies