Senior Mgr. Commercial Quality

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Abiomed Inc. is recruiting for a Senior Manager Commercial Quality located in Aachen North Rhine-Westphalia Germany or Würselen North Rhine-Westphalia 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 lead Commercial Quality activity for EMEA focused on compliant GxP commercial operations supplier quality management of distributor quality performance storage transportation kitting operations and field service. The incumbent will continuously develop and drive implementation of compliant fit for purpose controls on these activities globally with an unwavering focus on customer experience.

Key Responsibilities:

• Partners with the Abiomed Commercial and Deliver organizations to define customer priorities and quality plans to achieve customer requirements support growth and ensure compliant commercial and distribution operations in the EMEA region.

• Leads the EMEA Commercial Quality Team providing Quality Operations support to the European Distribution Center in Würselen and Customer Service team in Aachen inclusive of Kitting Distribution Transportation Customer Service and Field Service operations.

• Ensures strong development plans and succession plans are in place for all team members. Drives a Credo mindset and ensures appropriate personnel training is planned and achieved to support compliant operations within Commercial Quality.

• Executes Field Actions in the EMEA region including communications to Competent authorities and customers and resolution of questions and issues. Creates and approves FSCA and FSN documentation for the region and ensures accurate record keeping and documentation management of all field actions. May manage contracted services or resources to support field action activity.

• Supports all internal and external compliance audits as subject matter expert for Commercial Quality in EMEA. Interacts directly with Notified Bodies Competent Authorities and internal audit personnel.

• Implements aligned processes and procedures at Abiomed to ensure compliant efficient and effective Commercial Quality operations supporting the growth forecast for the Abiomed business.

• Connects the Abiomed organization to the broader J&J Commercial Quality and Distribution organizations to identify efficiency opportunities SME knowledge standard methodologies and cost improvement opportunities.

• Other activities as required by management.

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 10 years of diverse business background with specific quality regulatory and regulatory compliance competencies in the areas of commercial quality supplier quality escalation and field action handling storage transportation and distribution.

• 5 years of quality management experience in positions of growing responsibility supporting large multi-site global organizations.

• Experience with the global demands of the role specifically: multi-cultural / multi-country organizations and healthcare regulatory requirements.

• Previous extensive experience working directly with Notified Bodies and EU Competent Authorities or other regulatory agencies e.g. DNV MEDCERT BfArM SwissMedic MHRA

• Fluent in English.

• Ability to travel up to 20% regionally and globally.

Preferred:

• Professional working proficiency in German preferred. Additional EMEA language capability is a plus.

• Ability to build consensus and impact outcome without always having line authority and can achieve trade off decisions across the organization.

• Must have strong collaboration and influence leadership skills to partner optimally across functions and operating units.

• 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 organized and able to lead people within a complex global environment.

• Excellent communication / presentation skills able to inspire trust and quickly build credibility within the Quality & Compliance Supply Chain and Commercial organizations.

• Hands-on orientation focused on the customer. Accountability with a desire to commit 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.

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.

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