Senior QA Manager Operations

Johnson & Johnson•Anasco, PR

About The Position

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. 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 QA Manager Operations to be located in Añasco, PR. The Senior QA Manager Operations plans, directs, and conducts projects of major scope and significance to the Company with full technical responsibility for interpreting, organizing, executing and coordinating resource allocation, assignments and timely project delivery. May contribute to inventions, new designs or techniques which are materially significant in the solution of important problems. Supports Base Business processes and supervises, leads and mentors other professionals and engineers, advises top management on technical matters and utilizes Quality Engineering tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Utilizes Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. Ensures effective risk management is utilized to prevent unanticipated failure modes and improve capability of processes including process, product and computer-based validations. Ensures compliance with regulations and promotes good manufacturing and/or laboratory practices and good product quality engineering practices. Leads the development and implementation of initiatives to assure process robustness and regulatory compliance within the primary areas of responsibility.

Requirements

A minimum of a BS in Engineering is required.
A minimum of 8 years of work experience in Quality Engineering or Quality Assurance functions within the Pharmaceutical or Medical Device Industry, including managing and hosting of regulatory bodies and agencies.
Experience with validation, cGMP’s and/or GLPs in a FDA regulated environment
Must be fully bilingual (English/Spanish, read, write and speak).

Nice To Haves

Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
The ability to perform "hands on" troubleshooting and problem solving.
The ability to “think on the feet” and providing sound judgment is high desired.
Excellent technical understanding of manufacturing equipment and processes
A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
Strong mentoring, coaching and leadership skills
Demonstrated project management and project leadership abilities

Responsibilities

Supervise the personnel, deployment and execution of the Quality System within the primary areas of responsibility to ensure compliance and to support the effectiveness and efficiency of the manufacturing process.
Observe and promote all regulatory compliance (QSR, ISO) policies, and rules and procedures, and Validation System requirements established by the Company.
Serve as Quality Assurance/ Engineering SME for assigned areas.
Execute supervisory related activities (i.e. timecard management, activity planning, handling of disciplinary actions).
Ensure all direct personnel are properly trained to perform their assigned functions in accordance with applicable GOP’s and WI’s.
Work with multi-functional teams to establish operational plans and ensures uninterrupted support to manufacturing operations.
Serve as a consultant in the quality related operations and quality systems applicable to the plant products and processes. Provides guidance and recommendation as needed.
Provide support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary
Lead or aids in the execution of validation and verification activities associated with process, equipment, csv, laboratories and test methods.
Write process, test method, equipment, cleaning and computer-based validation protocols and reports.
Conduct and/or participate in troubleshooting and/or deviation investigation efforts including NC, CAPA and complaints.
Execute Six Sigma / Process Excellence projects to characterize and optimize procedures, equipment or processes.
Create and review documents, SOP’s and practices and devices new approaches to problem solving.
Identify, prioritize, and execute quality and cost improvement projects that support business goals by using engineering principles, tools, and practices