Quality Complaint Lead

Johnson & Johnson Innovative Medicine•Gurabo, PR

1d•Onsite

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. Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Gurabo, Puerto Rico, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Quality Complaint Lead to be located in Gurabo, PR. The Quality Complaint Lead executes assigned responsibilities in line with established Company and Corporate Standard Operating Procedures, J&J Policies, and applicable Rules and Regulations, as well as current cGMP guidelines. Utilize effective time management and risk assessment tools. Oversee and coordinate the handling of Customer Complaints, supervising the staff involved in this process and monitoring associated metrics. Collaborate with the Operations Group to facilitate the customer complaints investigation process.

Requirements

BS/MS in a Science field or a related area.
Requires a minimum of six (6) years of experience in the pharmaceutical industry, with knowledge of cGMPs, record control specifications, and experience in regulatory inspections.
Experience in the Quality Assurance Unit.
Strong presentations skills and proficient in using MS Office applications, including Word, Excel, PowerPoint, Complaints Management Systems, and the Internet.
Fluent in both oral and written English and Spanish, with excellent technical writing communication skills in both languages.
Strong understanding and adherence to the conformance for the customer complaint investigation process, Global Standards, Company Policies, and Company Procedures.

Nice To Haves

Business Savvy
Compliance Management
Corrective and Preventive Action (CAPA)
Cross-Functional Collaboration
Developing Others
Fact-Based Decision Making
Give Feedback
Human-Centered Design
Inclusive Leadership
ISO 9001
Leadership
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Risk Assessments
Standard Operating Procedure (SOP)
Team Management

Responsibilities

Responsible for directly supervising the customer complaints group.
Ensure that all external customer complaints and internal complaints from affiliates are handled, evaluated, investigated, and documented in a timely and effective manner, in accordance with cGMP's, Johnson & Johnson policies and procedures.
Monitors monthly metrics of complaints, such as compliance with the schedule, cycle time, and identification of major contributors.
Escalates issues to the Site Quality Head and Senior Manager Quality Assurance.
Actively participates in complaints forums, which occur regularly throughout the year, sometimes at unconventional hours.
Collaborates with other functions within Johnson & Johnson to ensure consistent practices for complaint investigations.
Inform management of critical compliance issues and communication with multi-disciplinary teams responsible for resolving problems.
Reports complaint metrics and monitors, complaints and site metrics in the Quality Management Review (QMR).
Actively participates in projects, programs, safety and environmental training, cGMP, SOPs, and other activities promoted by the company to encourage employee involvement and professional development.
Supports the Senior Manager Quality in driving quality and personnel objectives aligned with the company's goals and objectives for the Quality Assurance area/department.
Provides immediate actions and support to ensure timely resolution of quality matters, which may include escalations, product field alerts, and product recalls.
Responsible for creating and monitoring job descriptions, developmental plans, and performance appraisals of direct reports.
Optimizes available resources, such as people, facilities, equipment, and materials, to improve current standards and implement new ideas.
Allocates resources effectively to achieve task performance and desired product outcomes.
Provides training to direct reports to ensure compliance with curriculum requirements and to enhance their skills, abilities, awareness, and technical knowledge, to prevent deviations and achieve expected results.
Ensures a safe working environment for direct reports in accordance with current Safety Policies and Procedures.
Reports and take immediate action if unsafe situations are identified.
Conducts the recruiting process for new associates, including justification, interviewing, selection, and final hiring.
Administers disciplinary actions to direct reports, if applicable, in alignment with Human Resources Policies and Procedures.
Ensures proficiency in current systems, such as SAP, Enterprise Learning Management System (ELMS), Documentation Management System, Investigation System (TrackWise), and LIMS.