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Senior Quality Assurance Associate (m/f), Customer Logistic Services Quality & Compliance Germany
Requisition ID: 1700168116W
Johnson & Johnson MEDICAL GmbH is a subsidiary of the Johnson & Johnson group acting worldwide with more than 129,000 employees. Since 1930, our responsibility towards our staff has been, and still is, an essential element of our Credo. High quality standards and an inspiring identification with our products and services distinguish us. Johnson & Johnson MEDICAL GmbH is a trendsetter in the area of medical technology.
We are currently hiring a Senior Quality Assurance Associate (m/f) Customer Logistic Services Quality & Compliance Germany. The position holder will be located in Umkirch with requirement of 25% travel within Germany and DACH Cluster.
- The Senior Quality Assurance Associate Cluster Quality & Compliance (Q&A), Customer & Logistics Services (CLS) Germany reports solid line to Johnson and Johnson’s Sr. Manager DACH Cluster Distribution Quality & Compliance, CLS Q&C EMEA
- The position is accountable for the oversight and execution of a Facility and Quality Management Systems remediation program at partner facility (internal Distribution Center and 3PL) in Germany, that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors
- The position serves as a single point of contact between the partner facility (internal Distribution Center and/or 3 PL) and the corresponding CLS cluster operational and Quality leads on Distribution Quality related matters (e.g. NC/CAPA, Customer Complaints)
- The position requires regular on-site liaison with the senior management of the partner facility in order to oversee implementation of quality systems, distribution, and quality management, with the need for regular status reporting and escalation of risks to a broad J&J stakeholder group
- The position optimizes quality systems and processes and ensures alignment with J&J expectation, identifies opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. The position understands current and emerging regulations and the impact to quality and distribution practices
- The position plans, coordinates, and directs, communication processes, and will be expected to flexibly manage their time between the partner facility (internal Distribution Center and/or 3 PL) and J&J CLS DACH as appropriate
- Undergraduate degree in engineering, scientific, business or QRC disciplines. Will accept the equivalent of 10 years relevant industry experience if no degree
- 5 years+ experience in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business
- Knowledge of GMP and GDP preferred
- It is preferred that the job holder is an experienced internal auditor or certifies lead auditor
- Change management and project management experience
- DC Q&C management
- Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
- Compliance experience, QMS experience
- Strong presentation skills
- Issue remediation experience
- Collaborative approach
- Managing complexity
- Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc
- Previous experience interfacing with regulatory agencies, and a history of success and credibility resolving complex regulatory compliance issues
- Fluent in German & English
- Organized, Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations
- Must have strong collaboration skills “hands-on” operational orientation
The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.
Johnson & Johnson G.m.b.H. (7980)