Director, US Plant Quality

Johnson & Johnson•Danvers, MA

2d•Onsite

About The Position

Abiomed is recruiting for a Director, US Plant Quality located in Danvers, MA. About MedTech 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 https://www.jnj.com/medtech 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.

Requirements

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, ISO13485
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 escalate issues in the face of competing priorities
Proven record of ability to train and develop staff
Requirement to be on site daily
Expected domestic/international travel of approximately 20%

Nice To Haves

Black belt or lean certified

Responsibilities

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

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year