Johnson & Johnson Careers
Director Quality & Compliance, ASP Europe
Requisition ID: 1805668164W
As the Director Quality & Compliance ASP Europe, you will be responsible for all aspects of quality, compliance and the quality management system as it applies to ASP Europe.
Quality site lead, and designated Management Representative, responsible for ensuring effective implementation of ASP Europe Quality Management System, the quality of ASP Europe products and services and for performance of related suppliers.
Liason for Operations Quality and Business Quality for EMEA ASP Europe.
Provides direction for ASP Europe Quality team including Quality Operations, Supplier Quality and Quality Systems.
Responsible for the development and management of ASP Europe quality staff.
Compliance & Quality Systems
- Designated Management Representative for ASP Europe with full responsibility and authority for establishing and maintaining the Quality System.
- Oversee the ASP Europe quality systems that support compliance, quality, internal audits, corrective and preventive action, records management, field actions, and post market surveillance. Responsible for hosting and the management of government health authorities, notified bodies and other third party audits/inspections.
- Responsible for the compliance and timeliness of ASP Europe activities including: Non- Conformance, CAPA, Audit Observation and Training
- Maintains ASP Europe quality systems and records in readiness for internal and third party audits. Assures that the quality system is in compliance with applicable global regulations and standards.
- Responsible for Management Review, serves and Management Representative.
Product Quality & Operations
- Provide quality support to global supply chain, distribution, production, and technical services activities by developing and setting quality goals, strategies, and identifying and escalating quality issues to ensure compliance.
- Assures timely and effective escalation of manufacturing related quality issues. Oversees disposition decisions on quarantined/held lots through the Resume Shipment process.
- Responsible for all quality aspects of ASP Europe manufacturing. Establishes quality infrastructure required to support operations. Monitors key indicators and assures manufacturing site quality staff are effective.
- Supports establishment of strategic supplier relationships to ensure supplier and external manufacturing, packaging and service providers meet quality and compliance objectives.
- Supports establishment of systemic approach and policies for evaluating and selecting potential suppliers, external manufacturers, development partners, acquisitions and alliances.
- Recruiting, performance appraisal, development and day to day management of ASP Europe Quality Staff. Communicate and institutionalize the ASP Values throughout the ASP Europe organization
- Position is located at ASP Europe headquarters in Zug Switzerland. Routine presence at the HQ site is required, some remote work is allowed. Up to 25% travel, domestic (Europe) and international.
- Minimum of 10 years; experience in medical device environments (Quality, R&D, Design control or a related field), 5+ years managerial experience with demonstrated people development and leadership skills .
- Knowledge of regulatory and business strategies to improve compliance profile. Expert knowledge of medical device design controls, ISO 13485, and Quality System Regulation 21 CFR 820.
- Ability to effectively negotiate and influence above, below and across the organization.
- Ability to work and communicate in a cross-cultural environment.
- Excellent communication skills both written and verbal.
- Highly developed influence, interpersonal, communication and conflict resolution skills.
- Strong team player capable of working collaboratively with business partners
- Ability to interact with all levels and disciplines within the organization.
- Must be able to work on multiple priorities and tasks simultaneously, while acting in a decisive manner and demonstrating a bias for action.
- High sense of urgency, adaptable to meet rapidly changing priorities.
- Proven analytical/quantitative skills are required.
- Project management skills, with the ability to drive change and influence decision-making through multiple levels.
Cilag GmbH International (8525)