Sr Quality Excellence Manager QA/QS AT

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

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

THE OPPORTUNITY

The Senior Quality Excellence Manager (Quality Assurance/Quality Systems), Advanced Therapies Platform, is responsible for managing the governance related to and ensuring consistent deployment of all Quality Systems and related QA processes for the Advanced Therapies Supply Chain, in line with the ATSC Quality platform strategy. This role will lead global QA and QS initiatives and monitor relevant KPIs to ensure effectiveness of the related quality processes/systems and identify/implement continuous improvement opportunities.

Key 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.

IT’S ALL ABOUT YOU

To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:

• Bachelor’s degree
• 8-10 years of relevant experience
• Experience with Quality Assurance and Quality Systems is required
• Knowledge of cGMP regulations and guidance for FDA/EU is required
• Knowledge of the business environment inside a Quality organization across various roles is required
• Experience in Biologics and/or Cell therapy is preferred
• Strong leadership capabilities, in particular as a change agent and ability to lead system implementations is required
• Proven track record working in and supporting a global matrix environment
• Ability to translate strategy to execution and drive the organization forward in executing and delivering results
• Ability to analyze issues and determine how to apply policies and processes to meet goals
• Strong organizational, conflict management and decision-making skills
• Ability to resolve and manage operational and quality problems
• Fluent verbal and written English communication skills; other language skills advantageous

Close connection required with the platform (mainly ATQ Site Quality Heads and similar roles above site), as well as with key stakeholders in Quality (PQM/MQSA/PRC) and business partners (Ops/MSAT/DPDS).

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.