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Quality

Senior Manager Commercial Quality UK

  • Job Title Senior Manager Commercial Quality UK
  • Function Quality
  • Sub Function Quality Assurance
  • Category Senior Manager, Quality Assurance (PL8)
  • Location High Wycombe, England, United Kingdom
  • Date Posted
  • Requisition Number 2406162177W
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Description

At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we’re empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.

All of this is possible because of our people. We’re passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.

J&J Innovative Medicine (Janssen) is recruiting for a Senior Manager Commercial Quality UK  to be located in UK.

Role Purpose

This position serves as a local/cluster leader of quality and compliance and oversees the Commercial and Deliver activities of all regulated functions in a LOC / Cluster.

The Quality Head is responsible for 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.

The Quality Head is the first point of contact for quality matters for the Managing Director and local board of the LOC / Cluster.

This function assures the quality and compliance of the product and services for the LOC/Cluster markets.

Key Role Activities

1. To define and implement the UK and Ireland LOC Commercial and Deliver quality strategy in line with regional CQ strategy and local business strategy including:

o Oversight, monitoring and improvement of the LOC / cluster quality and compliance metrics

o Proactively partner with other commercial departments to ensure quality aspects of new launches, delisting and divestures are properly handled.

o Work with functional partners to ensure alignment of business quality initiatives with strategic business direction.

o Identify and sponsor local initiatives/projects to increase compliance and to reduce the cost of non-quality / non-conformance.

o Identify and sponsor local cross-functional / cross-sector leveraging opportunities for J&J.

2. To lead and co-ordinate the development and deployment of an effective LOC QMS

o Coordinate the establishment and maintenance of the local QMS.

o Contribute to the one QMS at EMEA / WW level for the commercial organizations via providing LOC inputs to regional / global representatives and seeking feedback on project status. Actively collects regional feedback and provides updates to CQ EMEA / SLT.

o Ensure local processes are compliant and consistent with applicable J&J policies, global and sector standards, global and regional processes (as applicable) and all applicable global, regional and local regulations.

o Ensure local compliance oversight of the entire organization, in coordination with the other regulated functions (Regulatory, HCBI, Medial Compliance, Legal, PV).

o Ensure compliance oversight and proper local training for related research activities (CM!).

3. Responsible to obtain and maintain the required QMS compliance certificates, licenses andquality agreements for the LOC/cluster, including:

o Understand, document and explain the legal and quality set-up of the LOC: certificates, delegation of authorities, SLA’s, intra company quality agreements, quality agreements with external parties.

o Set-up effective collaborations with other functional areas such as SC QA, CLS QA, BRQC, ESIQ and PV to ensure reliable product supply that meets regulations.

o Acts as the Controlled Substance Responsible Person for the UK LOC

o Acts as Quality Controller and Contact Person for the PQS under the UK MIA (IMP) licence.

4. Accountable for local release if mandatory by local regulations.

5. To be the LOC / Cluster lead for quality oversight and risk management via:

o Oversight and monitoring of complaints in an LOC / cluster.

o Triggering, leading and/or coordinating local, regional or global escalations and recalls regarding, product quality or compliance issues.

o Leading the local Quality System Management Review: Report to the Management Board of the LOC / Cluster the performance of the QMS and the adequacy of the quality resources.

o Leading / coordinating for auditing and inspection. Ensuring that the LOC quality systems for the commercial organization are in constant state of readiness for planned and ad hoc audits or inspections.

6. To be the LOC / Cluster point of contact for quality matters for:

o The local Managing Director and Local Board.

o The local leads for the regulated functions.

o All LOC employees involved in GxP quality and compliance activities (including commercial Janssen employees).

o Local Health Authorities, industry groups: Participate in Industry Association/Working Groups where present to anticipate, analyse current/emerging regulations/trends that impact Quality System, as appropriate.

o External stakeholders such as suppliers, distribution centres, 3PL’s

7. Manage the local/cluster CQ organization and resources

o Manage the local CQ employees reporting in full line to the LOC/Cluster (QH: G&O, performance reviews, talent development, succession planning …).

o Involve Regional CQ / CQ EMEA SLT for local hiring and promotion of local CQ employees and contractors.

o Manage the local CQ budget / expenses and obtain the yearly LOC approval of the local CQ budget

8. Manage the GMP/GDP and product quality aspects

o Act as 'Responsible Person' (GDP) on Wholesale Dealers Authorisation (WDA) as required by EU Directives and Guidelines or provide oversight for the activities when the named “Responsible Person” this associate is not the Quality Head. The 'Responsible Person' must ensure that the conditions of the WDA are being complied with and must ensure that the quality of the products are being maintained in accordance with the requirements of the appropriate Marketing Authorisations.

o Either personally carry out or delegate activities to ensure 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 CLS

o Have oversight of all such activities

Be responsible for the compliant Complaint Management process and any other activities that ensure Product Quality requirements are met.

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 when planning projects, developing materials, executing projects and contracting vendors

2. Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors

3. Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description

4. If commissioning contractors or third-party organizations, 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

• A background of working in pharmaceutical/biotechnology industries with a substantial experience of either Quality Assurance or Process methodologies. At least 10 years’ experience required.

• J&J Organisational awareness including J&J products, J&J culture, J&J IT tools.

• Experience in Quality and Project Management, be an expert in at least one regulated area.

• Knowledge of GMP/GDP regulations and understanding of the importance of this area to the function.

• Business acumen to balance safety, compliance and availability of product for a patient.

• Continuous development into current local and EMEA regulations, guidelines and industry quality standards.

• Excellent interpersonal, collaboration, networking and communication skills, self-motivated, clear thinker.

• Proven ability to prioritize risks and to manage multiple critical issues.

• Relevant university degree or business experience and qualifications in areas applying process methodologies.

• Capable of Analytical thinking and capable of summarising the key elements.

• Ability to leverage across LOC’s in EMEA / WW.

• Computer literate with good knowledge of the quality systems used in an LOC / J&J.

• Open for standardization: regional and local thinking, team player at EMEA level. Influence, leadership and ability to effectively operate at executive / board level, including assertiveness in conflict/challenging situations.

• Fluency in the national Language(s) and the English language is required

• External Body qualification / Certification as Internal Auditor is preferred

The QH should be capable to :

• Handle quality issues constructively with executives (Board members, local Health Authorities) as well as being capable to analyse details and to summarise status and mitigation plans.

• Take decisions, taking into consideration all aspects including regulations, business goals and patient safety. Take risk-based and facts-based decisions. Be a quality and compliance role model for all LOC members; further foster the quality mind set for all LOC activities.

• Prioritise.

• Stabilize during crisis situations.

Other special requirements

Flexible work hours and reachable in case of emergencies. Readiness to travel; amount of travel is mainly based on a case-by-case basis.

Goals and objectives and performance management of the QH is a shared responsibility of the local dotted reporting line and regional CQ.

Note: the LOC Quality Head

o Can delegate QH tasks to other quality workers, but the QH remains accountable for these delegated tasks.

o Can be a SME for a certain quality topic and should represent CQ EMEA in WW discussions and developments.

Maintain an awareness of current guidelines and other quality issues by reading journals and accessing internet websites in order to provide technical/pharmaceutical advice (to Janssen UK/ROI/EMEA) and decisions relating to contract manufacture, local quality inspection of incoming goods, Good Distribution Practice, regulatory compliance etc. SOPs relevant to this role (including any regulations etc)

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