Quality Lead Vaccine Therapeutic Area
Quality Lead Vaccine Therapeutic Area is part of the Product Quality Management
organization and will drive Quality aspects and strategy at the Janssen Vaccine
LT, to support Vaccine
TA’s strategy development to advance pipeline projects through close
collaboration and advancement of culture of quality
The Quality Lead is accountable for
the development and delivery of the quality strategies for the lifecycle of Vaccine
TA programs (dependent upon size of program, phase of development, priority,
etc.) in partnership with the Quality colleagues across BRQC, PQM, JSC Quality
and BQ, and VPAD, Vaccine discovery, Clinical development and other key
business partners. The individual in this role is the primary interface between
the TA/DAS and Janssen Quality organization to assure quality and compliance
deliverables are met for all of the Vaccine TA programs and the quality
strategy is aligned with the business strategy.
This individual utilizes strategic thinking along with their technical expertise to influence product/program strategies and Vaccine platform development. Lead and support implementation/optimization of Janssen quality commercialization processes to support Vaccine TA to advance its pipeline and leveraging existing processes, governances and programs as applicable. The individual represents the Single point of Contact (SPOC) for Quality on the Vaccine TA leadership team, Vaccine Development Committee, Vaccine Operational MT meeting, Vaccine CMC council and other key Vaccine governance teams associated with the product development and lifecycle management.
- Partner with Vaccine LT to drive Culture of Quality, ensure compliance to the JnJ/Janssen Quality standards, standardize Janssen Quality processes to Vaccine TA organization, particularly adapt best Janssen processes when there are organizational differences at the TA.
- Work with JSCQ, PQM, BRQC, and other Janssen Quality functions to ensure Quality team supporting the Vaccine TA is appropriately budgeted and resourced with the right capability.
- Ensure proactive identification and mitigation of quality risk, significantly reducing any risk to regulatory submissions, maximizing time to commercialization and consistent quality throughout product lifecycle.
- Operationally, this role needs to work closely with Leiden Vaccine, Bern Vaccine site QA and ESIQ for CMO vaccine sites, PQI team, CSC QA team in PQM and VPAD to ensure satisfactory GMP compliance status of the Vaccine TA.
- Lead Quality management review with Vaccine Leadership Team and ensure appropriate actions are taken by VLT.
- Work with Vaccine development team and JSC to ensure Vaccine platform technology is set up for the planned Vaccine projects through participating network strategy and technology positions are established.
- Operationally supporting to ensure quality deliverables towards Vaccine TA projects are met with right quality, on time, and on budget. Take leadership in addressing system improvements, quality team capability development, and issue escalation and resolution.
- Acts as SPOC in issue management situations to Vaccine TA leadership team by working closely with cross functional teams.
- Act as an expert consultant / mentor to team/staff and other functional groups on quality and technical issues/matters.
- Interacts with global regulatory authorities as needed.
- Represents Quality in providing solutions to complex issues.
- Minimum of Bachelor’s degree, but advanced degree preferred in a scientific discipline
- Essential that the individual has excellent scientific & technical capabilities based on combination of qualification and experience.
- Minimum 10 years of experience in quality, compliance and/or regulatory affairs in a regulated industry, experienced in Vaccine products or Large molecule products is critical to this position.
- Experience in more than one quality related disciplines would be preferred, including but not limited to, product development operations, clinical studies, manufacturing operations and commercial distribution.
- Demonstrated track record and experience leading teams and programs at a strategic level, achieving results through collaboration, problem solving, and effective in influencing.
- Demonstrated leadership in bring products through to launch.
- Excellent leadership & communication skills, to ensure support for the Quality sub team members and alignment across the quality function.
- Excellent collaborative leadership style and ability to voice both concerns & opportunities constructively.
- Proven ability to drive proactive quality and ability to bring quality solutions to issues at a senior management level.
- Sound business acumen and ability to frame proposals as value propositions.
- Located in Leiden with occasional travel (max 10%).
Janssen Vaccines & Prevention BV (8852)