Johnson & Johnson Careers

Associate Director, Strategy and Operations

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


Job Description

Requisition ID: 0002

Johnson & Johnson is currently recruiting for an Associate Director, Strategy and Operations within Global Regulatory Affairs, Quality and 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.

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.co.uk for more information.

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 Associate Director, Strategy and Operations will drive the optimization and continuous improvement of the Global Quality Management System (QMS) elements within Janssen GRA, providing direction and standard approaches in alignment with other Quality groups within Janssen. In partnership with the GRA Q&C organization, and key business leaders across GRA, this role will identify areas of the QMS that are opportunities for optimization, remediation, innovation, and/or standardization across GRA.

In collaboration with GRA Data Analytics and Governance team, He/she is responsible for monitoring the effectiveness of the key GRA Quality Systems as part of the GRA Compliance Review Board, recommending actions to address gaps, improve the execution and efficiency of Quality systems (QS)and prevent future compliance gaps. Partnering with Enterprise and Segment groups to evaluate internal Quality Systems data and external data to identify trends and insights. This position will partner with Enterprise forums to stay abreast of new regulations and standards impacting the QS and build a plan to ensure GRA is prepared in advanced of their due dates.

You will be Supporting the Director, GRA Q&C Strategy and Operations as the voice of GRA with other Quality groups across Janssen and J&J, such as BRQC, BQ, JJQSS, and other global GxP functions during the development and implementation of quality processes and IT systems. Partnering with all the GRA functions to determine and communicate the impact of proposed processes and IT systems and developing an integrated implementation plan for the GRA organization.

Supporting the Director, GRA Q&C Strategy and Operations in creating and supporting a culture of innovation across GRA Q&C. He/she develops and fosters an environment of innovative thinking and learning, through benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress. You will identify and support cross-functional projects that impact GRA and removes barriers to support and ensure success.

You will support the development of the GRA Q&C organizational strategy, aligned with the overarching strategy of GRA and the strategy across key Quality partners (BRQC, BQ etc). You will have responsible for reporting to management on the progress of organizational goals and objectives. They will provide input to the Director, GRA Strategy & Operations to identify skills and competencies needed to enable the GRA Q&C organization to continue to evolve to meet emerging and future business challenges.

Responsibilities

  • Working with business partners to ensure alignment of GRA Q&C initiatives with strategic business direction. Creating and implementing processes and strategic direction based on enterprise and segment QMS alignments.
  • Leading and influences others as a liaison/ambassador between GRA Q&C and other GRA, Pharma, and enterprise departments to deliver results and build interdependent partnerships.
  • Collaborating with local, regional, sector, and Enterprise business functions to refine the vision and strategies for quality & compliance integration in line with applicable regulatory requirements.
  • Developing and leads innovative initiatives to improve business performance.
  • Employing the findings obtained from cross-company opportunities to establish a dedicated compliance culture of continuous improvement to align with business objectives.
  • Ensuring the integration of appropriate risk management with current and emerging processes.
  • Ensuring that the quality systems supporting the regional businesses are in a constant state of readiness for planned and ad hoc regulatory audits or inspections conducted by regulatory bodies, competent authorities, or other agencies. Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality & compliance.
  • Supporting development of organizational structure, and business requirements to accommodate business needs.


Qualifications

Do you have the following qualifications, experience and Knowledge?

  • University degree / Bachelor’s degree
  • You have extensive experience in Regulatory Affairs, QA, or another compliance-related area
  • A proven track record of effective communication skills required.
  • You can demonstrate your ability to resolve conflict, influence teams, and to build relationships in meeting organizational objectives, without formal authority required.
  • You are knowledgeable of management aspects of Quality Management or Regulatory Compliance in an international, global context, or in a regulated healthcare environment highly preferred
  • An excellent Regulatory knowledge and understanding of interactions with health authorities (e.g., FDA, EMA, or MHRA). Knowledge of what the pertinent regulations cover, how they're applied, and what their implications are.

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-Netherlands, North America-United States-New Jersey, North America-United States-Pennsylvania, North America-United States-California, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
0002