Johnson & Johnson Careers
Quality Head UK
High Wycombe, United Kingdom
Requisition ID: 1805692280W
At Janssen BQ UK, we support $600M market reaching more than 1.7 million patients with a scope of two Local operating companies(LOC's). The role is managing a growing market in an uncertain complex regulatory landscape driven by BREXIT.
We are looking to recruit for a Quality Head for our Janssen UK operating company. You will have responsibility for oversight of the Market Authorisation Holder requirements for licensed products in the UK and Ireland. In addition you will be responsible for the implementation and maintenance of a Quality Management System for pre and post marketing regulated activities in collaboration with the various leads of regulated functions including local safety officer, Head of Regulatory and Medical affairs.
Main duties & responsibilities:
•You will be developing and driving improvement in the Quality System (QS). Supporting QS Management Review, CAPA, NR, Internal Audit, Trending, Risk Management, Quality Planning and Failure Investigation.
•Acting as the QSMR Lead providing in-depth data analysis of product information to the QS Management Reviews (QSMR) for all the LOC’s under scope.
•Serving as lead on de-risking programs gathering appropriate input ensuring management of commercial business risks.
•Obtaining and maintaining the required QMS compliance certificates, licenses and quality agreements.
•Establishing effective collaborations with other functional areas; SC QA, CLS QA, BRQC, ESIQ and PV to ensure reliable product supply that meets regulations.
•Acting as 'Responsible Person' (GDP) on Wholesale Dealers Authorization (WDA) ensuring conditions of the WDA are aligned and quality of the products are being maintained.
•Reporting of metrics, working with LOCs t develop and delvier recovery plans.
•Identifying and leading strategic and tactical continuous improvement opportunities
•Partnering with commercial and other LOC functions to ensure quality aspects of new launches, delisting and divestures are managed appropriately.
•Active engagement with external regulatory authorities, including performing lead and support roles as required for UK and Ireland LOCs during Internal Audits, JJRC Audits and external inspections
•Partnering on the formulation of responses to JJRC and regulatory agencies in order to address QMS related observations. Collaborate on the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions and related commitments.
•Leading the deployment of QS Enterprise standards, BQ cross-sector and pharma sector SOPs.
•Standardising and demonstrate compliance policies, practices and metrics across the LOCs in alignment with cross sector standard methodology and enterprise standards.
•Maintaining current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings.
•Being a representative on quality and business teams at BQ Pharm global level, regional level and BQ Cross Sector level and Enterprise.
•Delivering results by encouraging and mobilizing people and teams while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.
Do you have the following skills, experience and education?
•Degree in Scientific or associated relevant technical / Quality discipline
•having 10+ years Regulated Industry experience
•Broad based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance
•A good working knowledge of Medical information, Regulatory Affairs, Pharmacovigilance, Supplier Management, Product Development and Procurement
•Proven knowledge of business impact of compliance issues, Regulatory auditing and risk management
•Demonstrating effective people management
Does this sound like the opportunity? If so please click to apply.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications 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
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)