Johnson & Johnson Careers

Process Partnership Manager

High Wycombe, United Kingdom; Cork, Ireland; Netherlands; New Jersey, United States; Pennsylvania, United States; California, United States; Beerse, Belgium
Regulatory Compliance


Job Description

Requisition ID: 0004

We are currently recruiting for a Quality and Compliance Process Partnership Manager within Global Regulatory Affairs, Quality & Compliance. This position is joining a globally located team, so can be based at any site within the UK, Belgium, Ireland or NJ/PA/CA, USA.


GRA Quality & Compliance is a newly formed organization, created to enable a single point of contact across Janssen for all topics under the span of quality and compliance for GRA. The Quality & Compliance Process Partnership team provide end to end, customer focused collaboration, through audits and inspections, quality investigation and corrective/preventative action management, driving dedicated process improvement and sustainable compliance.


You will support the GRA Therapeutic Areas and Regions. They will partner with Quality groups across Janssen and the Enterprise to use standard methodology and ensure alignment. You will use business understanding to assess areas of potential compliance risk and contribute to strategic discussions with GRA leaders to align on prioritized action plans. Following identification of issues, You will be able to drive the Quality Investigation process, partnering with Process Owners and business leaders to ensure appropriate corrective and preventative actions. In addition, Using your deep understanding of the processes and compliance framework to propose process improvements, focused on simplification, efficiency, customer satisfaction and quality improvements. The focus of the role is on relationship building and collaboration with colleagues to continue to strengthen the understanding of quality and compliance across GRA and build an adaptable model which meets the evolving needs of the business for the future.

Responsibilities:

  • Identifies and understands complex problems and recommends common, effective, compliant solutions within a global organization
  • Provides balanced leadership, managing compliance risk and business need
  • Partners with various Quality organizations to ensure audit and inspection readiness and to support investigations.
  • Collaborates with SMEs to provide input to process improvement and to the procedural document strategy
  • Manages regulatory compliance issues and recommends solutions. Performs analyses and dedicatedly sees opportunities for remediation or identification of improvement opportunities.
  • Supports process and system standardization initiatives; demonstrates GRA, Pharma, and Enterprise compliance policies, standards, practices, and metrics.
  • Acts as a liaison/ambassador between GRA QM and other GRA, Pharma, and enterprise departments, as assigned, influencing and working with the direct and indirect organizations to deliver results and build interdependent partnerships.
  • Supports/mentors GRA on quality issues and CAPA management processes and system(s).
  • Partners with RA colleagues to develop and exchange understanding of emerging issues


Qualifications

Do you have the qualifications, skills and experience we are looking for?

  • You have a University degree (e.g., Bachelor’s degree).
  • You gained working in Regulatory Affairs, QA, or other compliance-related area’s
  • knowledgeable of Quality Management and Regulatory Compliance in an international, global context, and in a regulated healthcare environment.
  • In-depth knowledge of Root Cause Analysis and CAPA development methodologies.
  • Experience in delivery of quality procedural documents or appropriate equivalent departmental standards.
  • Knowledge of what the pertinent regulations cover, how they're applied, and what their implications are, and knowledge of interactions with health authorities (e.g., FDA, EMA, and MHRA).
  • Strong understanding of how regulatory bodies approach inspections and how to respond to Health Authority observations.
  • Strong verbal and written communication, negotiation and partnering skills.
  • Proven ability to resolve conflict, influence teams, and to build relationships in meeting organizational objectives, without formal authority required.
  • Experience of process perfection, process improvement methodology.
  • Experience leading a team within a matrix environment to achieve shared goals in a time sensitive environment.
  • Ability to train colleagues on audit processes/audit readiness. Ability to design and or modify training and business aids to support business tools and processes.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

 



Primary Location
United Kingdom-England-High Wycombe-
Other Locations
Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Netherlands, North America-United States-New Jersey, North America-United States-Pennsylvania, North America-United States-California, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Compliance
Requisition ID
0004