Descripción de la oferta
Requisition ID: 1805706173W
Main responsibility of this position is to sustain Quality management system in Spain Customer Services, Distribution Centers (DC) and supervision of Suppliers (3PLs) of warehousing & transportation in accordance to applicable local regulations and J&J requirements.
Has the responsibility for ensuring that quality system and processes are implemented and maintained accorder to Business Quality Manual.
Spain CLS Q&C Lead
Functional Group: CLS Q&C
Direct Reports: N/A
Essential duties and responsibilities :
· Built and sustain positive relantionships with the 3PL
· Represent the company with health authorities in Product Quality activities when considered necessary by Quality Executive
· Implement the Quality System via transposition of the requirements of the requirements of CLS Q&C. Establish required processes and procedures to comply with applicable local regulations and J&J requirements.
· To control actions related to Quality & Compliance at local 3PL, including warehousing, transportation & reverse logistics including returned goods inspection and items for destruction verification, mainly for Jannsen Cilag SA, guarantying product quality, identity and traceability throughout the supply chain, ensuring that GMP/GDP are fulfilled.
· To control actions related to San Sebastian de los Reyes DC Quality Area (QACage) at local distribution center, specifically returned goods inspection and items for destruction verification.
· To collaborate in the customer notifications related to Recalls and/or Field Safety Corrective Actions when required
· Collaborate in the preparation of data for monitoring quality system performance versus local and J&J requirements via use of pertinent business and compliance metrics and goals, cooperating in the continuous improvement.
· Coordinate the effective implementation with CLS Operations / CLS CS
· Ensure Distribution Center/3PL Audit Readiness, in accordance to health authority requirements.
· Accountable for the oversight and execution of Quality Management Systems and compliance at DCs and 3 PLs in Spain that receives, pick, pack, store, inspect, and deliver finished goods to end users.
· Serves as a single point of contact to the corresponding CLS operational lead on Distribution Quality related matters and liaises with multiple Quality organizations to drive timely resolution of Quality related issues.
· Revision of Janssen Cilag income lots & Consumer lots to be returned to stock from returns, prior to RP approval if applicable
· Quality Auditor, if applicable
· Notify the QE with any substantive concerns regarding product quality, safety and/or compliance, as per Escalation procedures.
· Report al suspected adverse reactions, serious or non-serious, may be aware of within a maximun of 24 hours after being aware of it and communicate I to the Pharmacovigilance Department.
· As part of a cross sector organization, collaborate in any required cross sector CLS Q&C project or support to required areas
Other features of the job:
This role must maintain a close working relationship with local Commercial organization, with inclusion of specific Goals & Objectives related to current business priorities.
· Very valuable 1 or 2 years working experience in a quality role within an International Pharmaceutical/ Medical Devices Company.
· Valuable 1 or 2 years working experience in a quality role or similar
Academic Training and Knowledge
· Knowledge of ISO 9001 Standard or equivalent quality standards and J&J Quality & Compliance standards
· Knowledge of Pharmaceutical /Medical Devises & Cosmetics regulations.
· Audit Management experience (Health Authorities, Notified Bodies, J&J internal audits) and supplier audit.
· Bachelors or Master degree in Pharma or Bioscience with relevant experience and background in Quality area.
· User level knowledge of office IT and Excel
· Qualificaton for internal audis
· Excellent written and oral local language and English communication skills
· Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
· Strong collaboration skills and ability to build partnerships internally and externally
· Ability to effectively present information to Management and public groups
· Change management experience and influencing and interpersonal skills
· Analytical skills with bifocal approach, being able of strategic approach keeping tactical and detailed focus.
· Initiative and teamwork abilities
· Detail oriented
Spain-Community of Madrid-Madrid-
Johnson & Johnson, S.A. (8500)