HireDiversity

Bogotá, CO

CLS Quality and Compliance Manager-000008PX

Description

CLS Quality and Compliance Manager Northern Region - Requisition Number 000008PX

"Johnson & Johnson companies are equal opportunity employers"

Description

Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care.

Searching the best talent for: CLS Quality and Compliance Manager - Northern Region

Position general description

Is accountable for the oversight and execution of QMS and compliance at the cluster DCs. Serves as the Q&C support to CLS partners in the cluster on Distribution Quality related matters. Drives timely resolution of Quality related issues and QSIP at the DCs. Implements Enterprise and CLS Q&C strategies and standards. Services as the business expert on QMS, distribution, and Quality management. Support main Standards implementation in CLS space: CAPA, Training, Transportation/Temperature Control execution, Orthokit/Loaner kit, Re-packing/Re-label , Purchasing Control

Main responsibilities

· Responsible for Northern Cluster, managing 1 internal DCs and the oversight of 13 "3PLs" (6 directly).

· Assure flawless execution on all inbound and outbound services (storage conditions, receiving inspection, quarantine/ hold process, damaged product disposition, destruction control/monitoring, pick/pack, quality oversight), as well as improving current capabilities in Quality & Compliance processes for critical processes.

· Manages maintenance of consistent procedures involving standard operating procedures management, document flow, archiving and regulatory practices.

· Enforces internal policies and procedures to assure that the Internal DCs and 3PLs are operating under a state of control and in a manner consistent with applicable laws, regulations and policy.

· Uses established written policies to ensure implementation of appropriate documents and procedures to assure day-to-day decisions are well supported, and clearly and properly documented.

· Oversees appropriate performance monitoring systems ( periodic audits, spot visits)

· Ensure that non conformances investigations are documented and submitted to appropriate management.

· Manages immediate staff and acts as subject matter expert for the department

· Assure Supplier Program Management execution, including Supplier Quality Agreements and qualification for Dist., Logistics, Transportation, Materials)

· Foster Quality Systems robustness ( Housekeeping, Pest control, non conformances investigation, CAPA investigation/implementation, Mgt review, ERC/SRC/Health Authority audit mgt …)

Position report to: Q&C Sr Director

Cualificaciones

Minimum 6-8 years of related experience in Pharmaceutical, Cosmetic and Food Industry background.

English speaking is required, multi language skills are preferred

Countries legislation knowledge (Cosmetic, Medical Device and Drugs) is preferred.

Global Leadership Profile Competencies

Big Picture Orientation with Attention to Detail ~ able to operate in two "worlds" simultaneously e.g., growth and cost control, enterprise and operating company success; sees the why as well as the what; can zoom in or out as needed

Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset

Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed

Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent

Other Considerations

Travel percentage 40 %

Submit your resume by: December 7th

Primary Location

Bogota, Colombia

Organization

J&J MD&D

Ubicación principal: America Latina-Colombia-Distrito Capital de Bogotá-Bogotá

Organización: Johnson & Johnson de Colombia S.A. (7755)

Área: Quality Assurance