от компании (организации): Johnson & Johnson в городе (населённом пункте): Москва, Россия
в отрасли экономики "Информационные технологии, интернет, телеком" → "Управление проектами"
с заработной платой: по договоренности
Вакансия № 25890689 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 28 августа 2024 года.
Дата обновления вакансии № 25890689 на сайте Работа в Москве и Московской области (МО, Подмосковье): Среда, 25 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 25890689 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
более 6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Commercial Quality Manager Russia & CIS
Janssen as a part of Johnson & Johnson Family of Companies is looking for a Commercial Quality Manager Russia & CIS located in Moscow.
You will serve as a local / cluster leader of quality and compliance and oversees the quality status of all regulated functions in Janssen Russia and CIS for Commercial and Deliver activities (hereinafter ‘LOC’).
You’ll be 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 applicable J&J Quality Policy(-ies) and that all applicable global, regional and local regulations are met in the LOC.
You’ll be 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.
YOUR responsibilities & YOUR impact:
1. To define and implement the local / cluster quality strategy in line with regional Commercial Quality (CQ) strategy and local business strategy including:
- Oversight, monitoring and improvement of the LOC / cluster quality and compliance metrics.
- Proactively partner with other commercial departments to ensure quality aspects of new launches, delisting and divestures are properly handled.
- Work with functional partners to ensure alignment of business quality initiatives with strategic business direction.
- Identify and sponsor local initiatives/projects to increase compliance and to reduce the cost of non-quality / non-conformance.
- 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
- Coordinate the establishment and maintenance of the local QMS.
- Contribute to the one QMS at EMEA / WW level for the commercial organisations via providing LOC inputs to regional / global representatives and seeking feedback on project status. In case the Quality Head is the representative he/she actively collects regional feedback and provides updates to CQ EMEA / SLT.
- 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.
- Ensure local compliance oversight of the entire organisation, in coordination with the other regulated functions (Regulatory, HCBI, Medical Compliance, Legal, PV).
- Ensure compliance oversight and proper local training for related research activities (CM!).
3. Responsible to obtain and maintain the required QMS compliance certificates, licenses and quality agreements for the LOC/cluster, including:
- 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.
- Set-up effective collaborations with other functional areas such as SC QA, Deliver QA, BRQC, ESIQ and PV to ensure reliable product supply that meets regulations.
4. Accountable for local release, namely:
- Execution of the process on Input of drugs in civil circulation in accordance with requirements of Federal law 61 "Drugs Importation and circulation" in Russian Federation;
- Signing of the Confirmation of Conformity of the medicinal product with the requirements established during its state registration as a person authorized by the manufacturer in order to input the drugs in civil circulation in Russian Federation.
5. To be the LOC / Cluster lead for quality oversight and risk management via:
- Oversight and monitoring of complaints in an LOC / cluster.
- Triggering, leading and/or coordinating local, regional or global escalations and recalls regarding, product quality or compliance issues.
- 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.
- Leading / coordinating for auditing and inspection. Ensuring that the LOC quality systems for the commercial organisation are in constant state of readiness for planned and ad hoc audits or inspections.
6. Manage the local / cluster CQ organisation and resources
- Manage the local CQ employees reporting in full line to the LOC/Cluster (QH: G&O, performance reviews, talent development, succession planning etc.).
- Involve Regional CQ / CQ EMEA SLT for local hiring and promotion of local CQ employees and contractors.
- Manage the local CQ budget / expenses and obtain the yearly LOC approval of the local CQ budget
7. Manage the GMP/GDP and product quality aspects
8. Participate to Industry Association/Working Groups where present to anticipate, analyse current/emerging regulations/trends that impact Quality System, as appropriate.
We would love to hear from YOU, if you have:
- Higher degree.
- A background of working in pharmaceutical/biotechnology industries with a substantial experience of either Quality Assurance or Process methodologies. Preferably 10 years’ experience required.
- Experience in Quality and Project Management, be an expert in at least one regulated area.
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP, including any legislation/guidelines relating to controlled substances 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.
- 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.
- Advanced English (both written and oral).
This is what awaits YOU at J&J:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Competitive salary & annual bonus.
- Many employees benefits: medical and life insurance, meal allowance, fitness compensation, mobile allowance, pension program eligibility, etc.
Откликнуться на эту вакансию: Commercial Quality Manager Russia & CIS
Предыдущая вакансия:
Вакансия № 25890687 на должность Ведущий аналитик данных (SQL) от компании М-Холдинг в городе (населенном пункте) Москва