QA Manager Supplier Quality EMEA (m/f) Job

Job description

QA Manager Supplier Quality EMEA (m/f)-00000YZADescription"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
Cilag AG in Schaffhausen manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products and we have an impressive pipeline of new and innovative products.
Janssen Supply Chain is a division of Janssen belonging to Johnson & Johnson family of companies. Janssen Supply Chain is engaged in the manufacturing, global distribution and marketing of Pharmaceutical and Combination Products with markets spanning across Europe, Middle East and Africa, Canada, USA, Asia Pacific and Latin America.
External Supply Integration Quality (ESIQ) is a Global Quality organizational unit of Janssen Supply Chain which provides leadership and owns Quality and Compliance oversight on suppliers and external manufacturers who supply materials for Janssen drug products. With a global mindset, and owning expertise across all materials, with strong, compliant and adaptable working processes that are globally harmonized, ESIQ is an asset and Q&C center of excellence to the Janssen Supply Chain in regards to selecting the right external partners and securing the external supply chain.
For our ESIQ-Organization, we are looking for aQA Manager Supplier Quality EMEA (m/f)Quality and Compliance lead ensuring quality standards are achieved and maintained at suppliers through management, and oversight on Quality Operations functions for external business partners. This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), compliance audit activities, creation and management of risk mitigation plans for suppliers managed by ESI SQ EMEA. Ensures that business, quality and compliance goals adhere to J&J policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the JNJ credo and quality values in contact with the suppliers and external manufacturers and will comply with the JNJ regulations for ethic and business conduct in order to strengthen the reputation of J&J.This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and it interfaces JSC ESI Quality with the quality unit of suppliers.
Your main tasks will include
- Planning, execution, and documentation of the qualification and monitoring of third party suppliers who are sourcing API materials (product type 1-4) and DP materials (CL 1-4) to the Janssen Supply Chain for the manufacture of API Intermediates, APIs, Excipients and Packaging Materials for the manufacture of Drug Products respectively.
- Surveillance on the quality and compliance status for all third party supplied raw materials, intermediates, APIs, Excipients, and Packaging Materials.
- This QA function captures into all Janssen Supply Chain sites (chemical and pharma sites).
- The task profile comprises but is not limited to:
- Performing audits at suppliers
- Involvement in change management, deviations, escalations, compliance issues, recalls, field actions that are related to suppliers
- Provision of all information needed for the release/reject of suppliers in SAP (SAP master data)
- Establishment and periodic review of Quality Agreements
- Establishment and revision of Qualification Statements, periodic performance metrics, and qualification classification for suppliers
- Establishment and periodic review of the Schaffhausen JSC site audit plan, under reconciliation with the ESIQ SQ EMEA audit plan
- Initial assessment and qualification of suppliers for new product introductions
- This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and it interfaces JSC ESI Quality with the quality unit of suppliers
- Execution of monitoring and trending reports for suppliers.
- ESIQ SQ representative and subject matter expert during regular audits and health authority inspections at Janssen CilagQualificationsYour profileWe are looking for an initiative, flexible and analytical person who is willing to adopt changes positively, find constructive solutions, and can represent JSC towards third party suppliers.
Organizational and communicative skills are essential, as well as teaming with third party suppliers to identify and ensure that J&J best practices
- or adequate
- are utilized.
- Professional experience and skills are needed as follows:
- University degree in a life science discipline, e.g. Chemistry, Pharmacy, Microbiology
- 5 years experience in pharmaceutical industry (production and/or quality department) at a minimum
- Familiar with GMP
- and International Conference on Harmonization (ICH)
- regulations
- Ideally 1-2 years experience as an auditor in pharmaceutical industry
- Ability to work in a global matrix environment
- Fluent in English and German language
- Knowledge of IT applications, e.g. MS Office and ideally SAP/ Trackwise
- We are offering you a multifaceted position with flexibility in terms of responsibilities within a dynamic, international environment and travel of about 30% (international).We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure.
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.).Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen-SchaffhausenOrganization: Cilag AG (8562)Job Function: Quality