Job Information
J&J Family of Companies Sr. Analyst Commercial Quality in North Rhine Westphalia, Germany
Sr. Analyst Commercial Quality - 2406206357W
Description
Abiomed Europe GmbH is recruiting for a Commercial Quality Senior Analyst (EMEA), located in Wuerselen, Germany.
Due to significant growth, Abiomed is working to develop and enhance Commercial and Distribution capabilities globally, including Quality Operations support to these functions. The incumbent will be responsible for supporting multiple workstreams in support of this development activity, focused on implementation of J&J standards compliance for commercial operations, escalation and field action, 3PL logistics supplier quality, supplier quality management for distributors, storage, transportation, pack to order operations, repack/relabel, field service, product returns and material and product controls.
The incumbent will complete shop floor Quality responsibilities in the distribution center following standard operating procedures to ensure compliant, and efficient activities for the EMEA region, with an unwavering focus on customer experience.
This role is located at the Wuerselen distribution center in Germany.
Key Responsibilities:
Partners with the Abiomed Commercial and Distribution organizations to define customer priorities and quality plans to achieve customer requirements, support growth and ensure compliant commercial and distribution operations, with a focus on the EMEA region.
Completes commercial quality related escalations in accordance with Abiomed SOPs as directed.
Executes Field Actions in accordance with Abiomed SOPs as directed.
Performs shop floor Quality activities for all Wuerselen DC and Aachen related distribution, transportation, and customer service, including PTO (pack to order).
Approves, leads, or assists in investigations of non-conformances, and corrective and preventive action (CAPA) for EMEA distribution/PTO, transportation, and customer service.
Facilitates constructive interactions with suppliers to optimize logistics operations, encompassing effective communication, problem-solving, comprehensive training initiatives, and the deployment of new legislation and corporate requirements.
Reviews and approves assigned related change controls for EMEA distribution, transportation, and customer service.
Defines in collaboration with Abiomed Quality Management, processes, systems, resources, and SOPs, for the organization to align with the J&J policies, J&J standards, and applicable regulations. Develops proposals and options and builds consensus with colleagues on the solutions.
Implements the aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of substantial growth forecast for the Abiomed business.
Ensures appropriate self-training is planned and achieved to support compliant operations within Commercial Quality. Ensures technical and business self-development through robust development planning and execution.
Identifies and implements cost and efficiency opportunities in collaboration with business partners in support of the Patient First agenda.
Other activities as required by management.
Qualifications
Qualifications
Education:
Required: Undergraduate degree in science, engineering, or a related scientific field.
Preferred: Masters degree in business, science, engineering, or a related scientific field.
Experience and Skills:
Required:
This role requires a diverse business background, with specific quality, regulatory and regulatory compliance competencies in the areas of commercial quality, supplier quality, storage, and distribution.
Knowledge of SAP S4/HANA is required.
Knowledge of Quality IT Systems is required.
Builds consensus and impacts outcome without always having line authority and can negotiate trade off decisions across the organization. Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
Preferred:
Experience with multi-cultural / multi-country locations and healthcare regulatory requirements is helpful.
Previous experience working with global regulatory agencies, e.g., HSA, PMDA, TGA, notified bodies, etc., is helpful.
Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed.
Other:
Decisive and organized. Optimistic with a continuous improvement approach.
Excellent communication / presentation skills, able to inspire trust and build credibility within the Quality & Compliance, Distribution, and Commercial organizations.
Hands-on operational orientation focused on the customer. Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change.
High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Engages in open and honest communications to ensure effective change management.
Proficient in German and English. Additional European language capability is a plus.
National and international travel up to 10%
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Primary Location Europe/Middle East/Africa-Germany-North Rhine Westphalia-Wurselen
Organization Abiomed Europe GmbH Legal Entity
Job Function Customer/Commercial Quality
Req ID: 2406206357W