Johnson & Johnson

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Senior Manager QA Strategic Technical Programs

Job Description

Quality Assurance at Janssen Vaccines & Prevention in Leiden is a fast-developing department.

The Janssen Vaccines & Prevention Group is currently working on a big portfolio of Vaccines, to be developed at our site in Leiden and by external organizations. The QA Group is responsible for overseeing and supporting the quality systems, projects and facilities. The opportunities and the demands for the Quality Assurance department to shape and deliver the right quality are key for the success of the Janssen Vaccines & Prevention Group.

The Group is forward looking, working on improving processes, being customer focused and supports the need for speed. The team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.

The Senior Manager will report directly to the Site Quality Head. You will provide cross-functional strategic and program management leadership. The Senior Manager acts as interface between different functional teams. Is key to advice stakeholders, business partners and other quality teams.

Activities will include, but are not limited to:

  • Leads strategic Vaccines Quality project teams in a matrix environment to drive team accountability for quality deliverables and improve processes.
  • Focus is on Data Integrity, Equipment Validation and Digitalization programs
  • Ensures Global standards are implemented and applied in a lean and effective way and will be an interface between JVL and Global Quality.
  • Provides Quality training, coaching and support for the site and the point of knowledge.
  • Participates in LT’s for the specific programs and goals.
  • Leads key initiatives and joins escalation teams when applicable.
  • Be the key consultant and provides leadership for complex and regulatory topics related to Data Integrity and Digitalization impact.
  • Demonstrate business acumen, project management, communication, process management and team performance management.
Qualifications

Profile:

Qualifications for the function as Senior Manager QA Strategic Programs

  • A Master degree (MD, PhD, MSc, or PharmD) is needed.
  • A minimum of 8-15 years of experience in a Quality, Compliance, and/or R&D environment is required;
  • Highly qualified in data integrity, equipment validation and digitalization.
  • Understanding and knowledge of Vaccines Development and respective quality oversight
  • Demonstrated leadership of cross-functional work-stream teams maintaining focus, enthusiasm and momentum and an ability to drive projects and goals to completion is required
  • Highly knowledgeable on GMP. Pharm Industry and Vaccines in specific

The skills to be successful are:

  • Relationship building, partnering and influencing in a matrixed organization;
  • Customer focus, and understanding the Vaccines Business to connect and build the network to support in an effective way
  • Ability to work under pressure in a complex changing environment
  • Innovative, try new approaches and take prudent risks.
  • Experience in and/or knowledge of (pro-active) risk management in a regulated industry is required.
  • Clear communication.
  • Sharing knowledge, being a coach and a mentor
Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
R&D
Requisition ID
2105935557W
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist