Director, US Plant Quality

Job Overview

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 Med Tech, 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

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
People Leader

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Abiomed is recruiting for a Director, US Plant Quality located in Danvers, MA
.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at

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 Massachusetts 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. This leader will be responsible for Plant Quality in the Danvers, Woburn and Peabody locations.

• Develops a world class quality organization through talent acquisition and internal movements to support Abiomed's forecasted growth and ensure appropriate resources.
• 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.
• Ensure that FDA and other regulatory knowledge and experience is applied to all Manufacturing and logistics systems including the FDA QSRs (GMP, CAPA, etc), ISO 13485, MDD, CMDCAS and other national and international quality and regulatory requirements and standard.
• Develop statistically sound sampling plans and perform data analysis to drive continuous improvement and resolve quality issues.
• Develop, improve and maintain existing company quality objectives, and track and trend performance.
• Designs develop and maintains the Process Risk management programs to ensure the company has risk-based quality processes in place in all areas.
• Leads compliance support during FDA and other regulatory compliance inspections.
• Takes appropriate actions to build and maintain a working environment aligned with OUR CREDO.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Bachelors or equivalent degree in a Scientific or Engineering discipline is required;
Masters in Science is preferred.

• Minimum of 10 years of experience in a GMP-related field within a Med Device or biotechnology manufacturing facility.
• Minimum of 7 years Leading and Managing Quality Manufacturing and associated teams at the company or corporate level.
• Knowledge of global quality systems and regulatory requirements (21 CFR Part 820, ISO
  13485).
• Advanced skills with MS Office applications (Word, Excel, Access) and Adobe Acrobat.
• Ability to communicate and work independently with scientific/technical personnel.
• Excellent interpersonal, verbal and written communication skills are essential.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience with FDA (or Notified Body) inspections.
• Ability to quickly grasp technology, medical applications, and applicable regulations/standards.
• Ability to positively influence groups across an organization to embrace a common philosophy in collaboration with various department system owners.
• Strong ethics to elevate issues in the face of competing priorities.
• Proven record of ability to train and develop staff.

• Black belt or lean certified.

• Requirement to be on site daily.
• Expected domestic/international travel of approximately 20%.

Johnson & Johnson is an Equal Opportunity…