Company: Johnson & Johnson Family of Companies
Location: High Wycombe

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At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Role purpose
The BQ Manager is responsible for the GMP/GDP quality of, and meeting the applicable requirements for, the products and services marketed by the LOC/Cluster (including all named-patient materials NPP)
They are responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GMP/GDP activities the LOC/Cluster undertakes. This position is also responsible for the continuous improvement of the GMP/GDP status of the LOC/Cluster.
Supporting the QH on the implementation and maintenance of a Quality Management System (QMS) for regulated activities in an LOC (pre- and post-marketing) and ensures, in collaboration with the various LOC/Cluster leads of the regulated functions (e.g. Local Safety Officers (PV), Head of Regulatory, etc.), that the implementation meets the requirements of J&J Quality Policy POL-001 and that all applicable global, regional and local regulations are met in the LOC.

Key Activities
1. Support QH in defining and implementing the UK & Ire LOC quality strategy in line with regional BQ strategy and local business strategy:

  • Supporting and participate in local initiatives/projects to increase compliance and to reduce the cost of non-quality / non-conformance.
  • Identify and promote/support local cross-functional / cross-sector leveraging opportunities for J&J.
  • Monitoring and improvement of the LOC / cluster quality and compliance metrics. Accountability for metrics related to processes/steps overseen.
  • Contribute to the one QMS at EMEA / WW level for the commercial organisations via providing LOC inputs to regional / global representatives.
2. Implement, maintain and monitor the quality system for commercial organisations in the LOC/Cluster:

  • Acting as ‘Responsible Person’ (GDP) on Wholesale Dealers Authorisation (WDA) as required by EU/UK Directives and Guidelines. The ‘Responsible Person’ ensuring conditions of the WDA are being compiled with and must ensuring quality of the products are being maintained inline with the requirements of the appropriate Marketing Authorisation.
  • Ensuring that product is stored, handled and distributed according to J&J standards and all applicable regulations. Delegation may be to LOC quality people or to J&J Deliver.
  • Executing requirements regarding lifecycle management of GMP/GDP related documents and records to ensure regulatory compliance and business continuity. Including the preparation, update and approval of procedures assigned.
  • Responsible for maintaining the following site licenses: MS and WDA. Ensure that any requirements of Licences are fulfilled.
  • Reviewing, approving and signing delegated technical quality agreements and intra-company quality agreements, where delegated by the Quality Leader.
  • Coordinating external inspections, and report these and other relevant field action activity into the relevant systems.
  • Ensure appropriate management of Quality Issues (QIs) and CAPAs related to GxP. Specific responsibility for leading all aspects of Process and Product’s QIs and CAPAs.
  • Monitor Quality System performance versus local GxP and J&J requirements via use of pertinent business and compliance metrics and goals.
  • Providing input to the Quality Head for the bi-annual Quality System Management Review.
  • Notifying and engaging LOC Quality Head and Business Quality Region and other affected partners with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures. Have an active role in this process i.e. preparation of alert, slide deck and minutes along with presentation in meetings. You will be responsible for assessing the impact in the UK and Ireland of other critical issues as well as for the oversight of all related documentation.
3. Quality processes

  • Oversight of the following processes: Product Quality Complaints, PQRs, QIs and CAPAs related to processes and products, procedures management and its training to employees, Batch Management and Returns.
  • Ensuring that any local procedure related to these processes are compliant and consistent with applicable J&J policies, global and sector standards, global and regional processes (as applicable) and applicable global, regional and local regulations
  • Ensure a robust quality system is in place that describes the reception, quarantine, storage, release and distribution stages, which guarantees product quality, identity and traceability throughout the supply chain.
  • Implement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products.
  • Implement a robust process to receive and evaluate all returned goods before rejecting or re-issuing the goods in compliance with company standards.
  • Managing mandatory governmental re-testing by assuring that the correct methods are used, as applicable. and that all specific / national obligations plus J&J requirements are fulfilled.
  • Conduct regular (self-)inspections of GxP practices on the supply chain within the responsibilities of the Local Operating Company. Perform supplier audits as required.
  • Assure effective processes to handle product and AE complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner.
  • Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, CLS QA, the logistic department, other Cluster / LOC in EMEA and any other functions.
  • Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.
  • Support the QH in conducting recalls in a timely manner by leading and/or coordinating recalls locally regarding product quality or compliance issues.

Key Compliance requirements
1. Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed.
2. Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and followed.
3. Ensure inspection readiness with respect to personal training compliance, and availability of CV and individualized Job Description
4. If commissioning contractors or third-party organisations, put contracts in place and provide training so that these individuals also act in accordance with Johnson & Johnson HCC requirements when interacting with Healthcare Professionals and report adverse events and complaints (as above).


Qualifications


Do you have the following Skills, experience and knowledge?

  • Manufacturing / QA operations experience
  • A deep understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
  • up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP;
  • strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
  • knowledge and full understanding of the J&J Quality Policy and Standards, the Cluster / LOC QMS and CLS QMS
  • Eye for business to balance safety, compliance and availability of product for a patient
  • Teammate within region, ability to influence across LOC’s in EMEA / WW
  • Experience in Quality and Project Management, be an authority in at least one regulated area.
  • Continuous development into current local and EMEA regulations, guidelines and industry quality standards.
  • Excellent interpersonal, collaboration, networking and communication skills, self-motivated, clear thinker.
  • Shown ability to prioritize risks and to balance multiple issues.
  • Should be capable to handle quality issues constructively as well as being capable to analyse details and to summarise status and mitigation plans.
  • Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;
  • External Body Qualification/Certification as Internal Auditor is helpful
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.


Primary Location

United Kingdom-England-High Wycombe-
Organization
Janssen Cilag Ltd. (7360)
Job Function
Quality
Requisition ID
2005805803W

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