Quality Integration Leader

vor 19 Stunden

Zug, Schweiz Johnson & Johnson Vollzeit

Consideration for remote employees may be given on a case-by-case basis and if approved by the business.

The Ethicon Surgical Care business is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Biosurgery, Ethicon Energy, Ethicon Endomechanics, Ethicon Robotics, Megadyne, NeuWave, and Torax. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of mínimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to mínimally invasive surgery that continues to lead the industry today.

The Ethicon Biosurgery /Gatt Quality Integration Leader will be an integral part of the overall integration project team, which is focusing on developing the QMS at GATT to enable the business to be commercial launch ready to the Ethicon Biosurgery business strategy. The role is required to ensure that current clinical production and supply at GATT is maintained, but in the parallel process are developed and enhanced to ensure the QMS at GATT is matured to full integration to the Ethicon QMS prior to commercialization.

**Responsibilities**:

- Create and lead a QMS integration plan and team in alignment with the broader project integration and schedule
- Leads, through collaboration and matrix management with the acquired company (GATT) and JNJ stakeholders, to enhance existing GATT SOP’s, or create process where gaps exist to bring the GATT site into compliance with J&J policies and standards
- Be the voice of quality for the integration leadership, ensuring that the quality integration activities are weaved into the overall SC process and scale up
- Manages the response and remediation commitments from any external or internal compliance audits to ensure that GATT is compliance launch ready as per the overall business launch schedule
- Influence and guide the GATT teams and leadership in their migration to Ethicon J&J QMS
- Works with the Biosurgery franchise quality team/ NPI/LCM team to manage the design controls migration to enable NPI for GATT under the Ethicon process
- Communicates and escalates issues to the project team immediate supervisor and project sponsors
- Support building a training program to roll out the modified processes
- Supports cross-function systems integration in alignment with the overall integration plan
- Applies Basic Project Management and Process Excellence knowledge and skills
- Reviews process-related documents

**Qualifications**
Required:

- A minimum of a Master’s degree (or University equivalent) in polymer chemistry or comparable technical/quality education
- A minimum of 10 years’ experience in the life science industry
- A deep understanding of quality management systems in a regulated environment
- A minimum of 7 years of people management experience
- A background or experience working with polymer technology preferably in life science
- Knowledge of quality and manufacturing systems and processes and applicable regulations such as ISO 13485 and GMPs for biologics and medical devices
- Superior regulatory, technical, and business knowledge to develop operational strategies for continued quality assurance
- Very strong partnering, influencing, and change management skills
- Superior confidentiality management, personnel sensitivity and careful communication skills
- Well-developed problem-solving skills
- Ability to listen, learn, teach, and think strategically
- This position may require up to 10% domestic & international travel

Preferred:

- Other Advanced degree (or University equivalent)
- Pharmaceutical, medical device, OR combination products experience
- Proven track record in te

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