Senior Manager, Supply Chain Quality

J&J Family of Companies • Guaynabo, PR • 1d ago

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Guaynabo, Puerto Rico, United States of America

Job Description:

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

We are searching for the best talent for Senior Manager, Supply Chain Quality to be located at Guaynabo, PR.

Our journey to transform the MedTech Supply Chain Quality (SCQ) operating model continues, as we work to enable our vision of leading the way for the customers and patients who count on us. This position will ensure that we are better aligned to support the needs of the business, ultimately helping to transform the way we serve customers and patients with high-quality and compliant products each and every day into the future.

This position is responsible for maintaining high quality product supply to our customers through strategies that drive continuous Quality Excellence, including reducing risk and maintaining compliance. In addition, this position will identify and/or drive key opportunities, positioning SCQ a competitive advantage by optimizing and standardizing processes.

Key Responsibilities:

Provides strategic and operational support to the Senior Director, Supply Chain Quality (SCQ) for the Surgical Vision (SV) franchise.

Supports the development and maintenance of SV SCQ multi-year Strategic Plan (Quality Roadmaps) based on franchise/site needs and in alignment with MedTech Quality & Compliance (Q&C) strategies and aspirations. Gathers insights through sources of input, collaborates with Site Quality Heads and global business partners to translate strategies and insights into initiatives, and establishes and tracks progress as directed.

Drives strategies associated with Service, Quality, Cost, and People enabling platform Strategic, Financial, and Long-Range Financial Planning:

Identifies and drives risk reduction and cost reduction initiatives.

Identifies and drives Quality optimization activities including (e.g., validation and acceptance activities).

Identifies opportunities and drives globally harmonized Quality Systems.

Supports JJSV sites in managing continuous project improvement initiatives, providing technical and tactical leadership to help meet established schedules and resolve issues.

Supports network projects aligned to the Supply Chain Quality organization.

Represents JJSV on global MD Quality teams and working groups, as required, providing input into global MD initiatives.

Provides pre-and post-inspection support for FDA, Notified Body, and other Health Authority inspections, which may include inspection readiness activities, direct interaction with inspectors/auditors, and establishing response strategies to address observations/nonconformances.

Qualifications

Education:

Bachelor's degree in a Life Science, Engineering, Physical Science, or equivalent is required.

Experience/Skills

Required:

Eight plus (8+) years of related experience and/or training in a regulated environment (medical device and/or pharmaceutical preferred).

Active management experience including direct supervision and matrix management.

Demonstrated knowledge of ISO 13485, 21 CFR Part 820, EU MDD/MDR, and MDSAP.

Demonstrated experience managing Quality Systems as well as experience with regulatory requirements.

Demonstrated knowledge of manufacturing/quality principles and practices.

Front-room role experience with FDA (or similar) and Notified Body inspections.

Strong verbal and written communication to all levels of the organization, influencing, and leadership skills.

Strong project management and problem-solving skills.

Ability to effectively manage people (both directly and indirectly) and manage projects that include cross-functional teams representing diversified areas.

Ability to build strategic partnerships to accomplish company goals in a team environment.

Ability to handle multiple projects simultaneously and the judgement to discern and resolve major quality issues.

Ability to work in stressful/fast paced environment.

Preferred:

Multi-functional experience (Quality, Planning, Operations, Engineering, etc.).

Knowledge of specific business practices and software applications.

ASQ or Industry recognized Certification.

Other:

This position may require up to a 20% of domestic and/or international travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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