Site Quality Leader (Director)

at  Johnson Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/
Abiomed is an innovative medical device business with an inspiring mission “Patients First,” and a unique guiding company principle " Recovering hearts. Saving lives.” With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.
Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.
Abiomed Europe GmbH, Johnson & Johnson MedTech is recruiting for
The Site Quality Leader (Director), (w/m/d) located in Aachen, Germany
The Site Quality Leader (Director) has the responsibility for driving continuous quality improvements, maintaining supply chain compliance, providing franchise support, and presenting internal and external customer facing needs to Site Leaders and Business Unit partners. This includes leadership in the delivery of critical Quality Control initiatives in manufacturing, receiving and product release for Medical Devices. In addition, the Site Quality Lead of Aachen will identify and facilitate the implementation of key capabilities at the site that will give the Quality organization a competitive advantage. In this role, they will coordinate regional efforts related to compliance, technology investments, regulations, and resource management/optimization.
The associate partners with Site and Business Unit leaders to drive end to end Supply Chain Quality execution governance, alignment, and optimization across the network, including development and execution of strategies. Responsibilities include collaboration in programs that might impact site operations from a regulatory, compliance or optimization standpoint. In addition, this role will also work closely with New Product Introduction teams to ensure standard methodologies are in place for product launch stabilization (compliance and efficiency). It is expected that the associate will engage the business for the inclusion and integration of additional relationships.

Major Duties & Responsibilities

• Assure execution of the quality management system at the site and apply process excellence tools/ methodology for continuous improvement and predictability.
• Maintain the site in compliance with applicable regional and global Quality System laws, regulations, and standards.
• Maintains a deep understanding of quality system regulations & standards related to the medical products manufactured at the site, including but not limited to US FDA 21 CFR parts 820, ISO13485, Canadian Medical Device Regulation, European Medical Device Regulations, ANVISA, TGA, Japan MHLW, and China GMP.
• Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
• Serve as Management Representative per ISO13485 & FDA QSR and as Responsible Engineering Manager per JPAL requirements for the site.
• Report Key Performance Indicators to top management on the performance of the quality management system and any need for improvement.
• Describe important tasks or duties, not mentioned above, that are performed infrequently and are not critical to accomplishing the essential functions of the Job
• Develops a world class quality organization through talent acquisition and internal movements to support Abiomed’s forecasted growth.
• Ensures the promotion of the awareness of the regulatory and customer requirements throughout the manufacturing site.
• Ensures that the Quality System is regularly audited/reviewed and that changes needed are implemented as required.
• Serves as a leader by recommending appropriate compliance efforts and proposing improvements to the Quality System.
• Ensure all associates are educated and trained in the regulatory requirements.
• Ensures the site has the appropriate resources with the right competencies to implement the Quality System.
• Maintains systems that assure only acceptable raw materials are used in processes and that only acceptable materials are shipped. Has the authority to stop production/shipments if quality requirements have not been met.
• Reviews and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, and non-conformances.
• Carries out, promotes, and observes all safety, industrial hygiene rules and regulations established by the Company.
• Takes appropriate actions to build and maintain a working environment aligned with OUR CREDO

QUALIFICATIONS

Required Qualifications

Required Minimum Education: University/Bachelor of Science degree or equivalent in the fields of: Quality/Regulatory, Business, Engineering, Science

• A minimum of ten (10) years of related work experience

Required Knowledge, Skills and Abilities:

• Proficiency (both oral & written) in English and in German is required.
• Deep knowledge of regulated healthcare environment and strong business acumen
• Functional knowledge of / experience in Quality & Compliance
• A transformational, strategic problem solver with superior capability to bring clarity to complex concepts and to mobilize and align the organization to deliver on the strategy and translate strategy into financial forecasts and business plans.
• Experience establishing and implementing long range financial plans and annual business plans for departments.
• Experience in leading organizations through cost optimization activities and providing guidance on opportunities.
• Ability to analyze and translate financial data to make effective trade-off recommendations in the Q&C portfolio of strategic investments, to balance risk while leading through change.
• Experience in establishing and leading portfolios of programs and reporting progress against investments and savings.
• Experience preparing business cases and capital appropriation requests.
• Build interdependent partnerships, and internal and external relationships.
• Superior team building and inclusion building skills.
• Strong blend of tactical and strategic management skills with ability to influence partners while managing competing internal stakeholder priorities.
• Excellent interpersonal skills and the skill to interact effectively with all levels of the organization.
• Demonstrated ability to establish and maintain effective working relationships with diverse groups of people in a global and matrixed organization.
• Positive relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally.
• Executive presentation skills

Travel on the Job:

Yes

• Up to 25%

Type of Travel Required:

• Domestic
• International

Required Years of People Management Experience:

• A minimum of 5+ years

Preferred Minimum Education: Master of Science Degree (Engineering)
Preferred Related Industry Experience

Experience in MedTech and Pharmaceuticals.

• Experience with sterile devices or sterilization processes.
• Experience in Quality & Compliance, Supply Chain, Commercial, and/or R&D.
• Organizational change management experience.

• Assure execution of the quality management system at the site and apply process excellence tools/ methodology for continuous improvement and predictability.
• Maintain the site in compliance with applicable regional and global Quality System laws, regulations, and standards.
• Maintains a deep understanding of quality system regulations & standards related to the medical products manufactured at the site, including but not limited to US FDA 21 CFR parts 820, ISO13485, Canadian Medical Device Regulation, European Medical Device Regulations, ANVISA, TGA, Japan MHLW, and China GMP.
• Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
• Serve as Management Representative per ISO13485 & FDA QSR and as Responsible Engineering Manager per JPAL requirements for the site.
• Report Key Performance Indicators to top management on the performance of the quality management system and any need for improvement.
• Describe important tasks or duties, not mentioned above, that are performed infrequently and are not critical to accomplishing the essential functions of the Job
• Develops a world class quality organization through talent acquisition and internal movements to support Abiomed’s forecasted growth.
• Ensures the promotion of the awareness of the regulatory and customer requirements throughout the manufacturing site.
• Ensures that the Quality System is regularly audited/reviewed and that changes needed are implemented as required.
• Serves as a leader by recommending appropriate compliance efforts and proposing improvements to the Quality System.
• Ensure all associates are educated and trained in the regulatory requirements.
• Ensures the site has the appropriate resources with the right competencies to implement the Quality System.
• Maintains systems that assure only acceptable raw materials are used in processes and that only acceptable materials are shipped. Has the authority to stop production/shipments if quality requirements have not been met.
• Reviews and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, and non-conformances.
• Carries out, promotes, and observes all safety, industrial hygiene rules and regulations established by the Company.
• Takes appropriate actions to build and maintain a working environment aligned with OUR CRED