Digital Apps Quality Oversight Manager.

Job content

The Janssen Supply Group, a member of the Johnson & Johnson family of companies, is recruiting for a Manager – Digital Apps Quality Oversight for the QC Operations Execution Systems team. Position can be based in any of our Operating Companies.

Key Responsibilities

The Manager - Digital Apps Quality Oversight performs QA oversight for the Digital Apps relevant business processes supporting the QC Operations group as well as provide QA and compliance mentorship for Global initiatives and projects. The role is accountable to support the implementation and maintenance of the Q&C Vision in decision making process.

The role is accountable to provide a standardized operational quality oversight for all Digital Apps and innovative solutions in this digital space and ensures maintenance of the right level of compliance of the Digital Apps business usage.

(Examples of Digital Apps: Real Time Release app, Datavision, CPV-automation)

The role is accountable to provide a standardized operational quality oversight for the ArcTic tool and its linked artwork governance processes, and ensures maintenance of the right level of compliance in the business usage upon.

Operational Quality Oversight Entails

• Establish a standardized quality and compliance oversight for Digital Apps in the GXP space, and in the ArcTic tool and its linked artwork governance processes.
• Provide leadership to ensure quality and compliance is maintained in Digital App’s process during execution while supporting novel solution implementations, as well as in the ArcTic tool and its linked artwork governance processes.
• Responsible for leading any Digital App’s deployment from a Quality Process perspective, according to system roadmap;
• Ensure all activities are executed according to expectations
• Ensure project timelines and deliverables are met
• Promote stakeholder engagement
• Escalate project issues to leadership to ensure areas of interdependency are appropriately accounted for and prioritized
• Manage / Prioritize QA Project Portfolio
• Ensure oversight of user accesses to GxP critical transactions.
• Prepare and Lead Digital App’s & ArcTic’s Quality Management Review meetings, CAPA and Change Control Boards
• Responsible for improving the key Digital App’s GxP & ArcTic artwork governance processes between the sites by connecting the QA users across the regions.
• Act as Quality approver for any global document linked to Master Data management in Digital Apps and artwork management in the ArcTic tool.
• Act as Quality approver for any Investigation, CAPA or Change Control related to Digital Apps and ArcTic tool.
• Maintains Digital App’s and ArcTic tool audit readiness. Support Periodic Review exercises led on Digital Apps and ArcTic tool.
• Facilitate System Forums/Community of Practice meetings. Lead decision making processes for above site Quality processes in partnership with site Quality teams
  
  

The candidate will be collaborating with Quality, Make, IT, Technology Quality and leadership in the Enterprise, Global and site organizations.

The position is able to provide leadership, take balanced and risk-based quality decisions in the space of Manufacturing operations as well as in the execution system and digital space.

Qualifications

Qualifications

• A minimum of University/Bachelor’s degree in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering). Master’s degree is preferred.
• Generally requires 10+ combined years of experience in Manufacturing, Quality Assurance, Quality Control, Validation or Engineering in vaccines/pharmaceutical industry. Solid understanding of the business environment inside a quality organization, across various roles (e.g., quality operations, quality control, quality systems, etc.) is preferred.
• Proven knowledge of applicable regulations is required. Working experience within an FDA/EMA GMP (Pharmaceutical, Medical Devices) regulated environment is preferred. Familiarity with ISO requirements. In depth knowledge of Data Integrity regulations required.
• Working knowledge of Quality systems such as: Investigation/CAPA, Change Control, Document Management, Management Review process, etc. required.
• Strong leadership/facilitation skills and ability to build respectful and productive partnership relationships with peers. Should effectively influence/negotiate at all levels of the organization.
• Working experience in navigating and dealing effectively within a matrix organization, managing complexity, engaging and collaborating with multi-disciplined teams across boundaries and influencing without line authority, including remote team members.
• Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required.
• Results oriented with strong track record of success in delivering on objectives. Sense of urgency and ability to zoom-in / zoom out.
• Conflict resolution and problem solver. Results and action oriented and highly collaborative. Ability to act independently and know when to involve/collaborate with others.
• Project Management skills and experiences. Knowledge of Project methodologies and process excellence.
  
  

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

Asia Pacific-China-Shaanxi-Xianyang, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Italy-Latina

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Quality

Requisition ID

2206055179W