Sr Quality Excellence Manager QA/QS AT at Johnson Johnson
Leiden, , Netherlands -
Full Time


Start Date

Immediate

Expiry Date

15 Oct, 25

Salary

0.0

Posted On

16 Jul, 25

Experience

8 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

System Implementations, Communication Skills, Strategy, Biologics, Cell Therapy

Industry

Pharmaceuticals

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

ARE YOU READY TO MAKE AN IMPACT?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.
We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

Responsibilities
  • Provide input to the platform QA/QS strategy and execute Advanced Therapies QA/QS projects that forward our strategies to maximize productivity, improve quality, reduce turnaround time, improve costs, and optimize QA and QS processes across the platform. Ensure that the status of Quality projects is clearly understood by all stakeholders and that the organization is achieving its strategic goals at the optimum pace. Support the ATQ LT in overall management, prioritization, risk monitoring, and course corrections as required. Assist and/or lead in specific projects, as needed.
  • Partner effectively with the ATQ Site Quality Heads, above site Quality and JJT teams, and JJRC to facilitate deployment of network wide quality improvement initiatives and quality system implementations. Represent ATQ platform in the planning and execution of corporate initiatives and system deployments. Provide input to the quality system strategy and manage the roadmap for AT; determine the need for and deploy fit-for-purpose quality systems.
  • Partner with ATSC Operations leadership and JSCQ Quality Insights team to implement and maintain the Advanced Therapies Quality Management Review (QMR) / Quality Council for the platform; ensure that AT sites provide the necessary data, information and updates for an effective QMR. Support the Tier process within JSCQ in the same context
  • Lead the Community of Practice Programs for selected Quality System Elements and Key processes
  • Lead and chair the Global AT Change Control Board meetings.
  • Lead the Chain of Identity (COI) and Chain of Custody (COD) Governance project and ensure CoE is established to ensure sustainability.
  • Lead NPI and fit for purpose quality system assessments to ensure the quality system & processes are supportive of the new modality requirements
  • Support manufacturing and lab network extension projects and ensure smooth transfer of knowledge and processes between internal and external nodes to ensure consistent deployment of standards, processes and systems in design and operational phases. Facilitate platform wide understanding and deployment of QA and QS processes and systems.
  • Partner with ATQ Site Quality Heads and JJRC to identify audit trends related to QS impacting the wider ATQ network and support identification of systemic corrective and preventive actions.
  • Advise Quality management of situations that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
  • Lead the management and resolution of multi-site quality issues in partnership with Operations, JJRC, DPDS, MSAT and other organizations.
  • Support regulatory outreach related to Cell & Gene Therapy. Facilitate review of quality/regulatory guidelines and standards
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