Senior Analyst, Business Process Quality

Johnson & Johnson•Gurabo, PR

About The Position

At Johnson & Johnson Innovative Medicine (IM), we are committed to delivering transformative treatments that improve patient lives worldwide. We strive to set new standards in quality and excellence through innovation and collaboration. Product Quality Management (PQM) plays a critical role in ensuring the highest standards of quality across our products. We are seeking a Senior Analyst, Business Process Quality to join our team, contribute to this mission, and make a significant impact on product quality and operational excellence. This is a global position, preferably located at one of our major JJIM manufacturing sites. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): North America- Requisition #R-052951 EMEA-Requisition R-053772 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Senior Analyst, Business Process Quality will be part of the Product Risk Management and PQM Support team, within Strategy Deployment & Excellence in PQM. The role involves ownership of selected Quality Management System (QMS) processes and provides essential support to PQM and other organizations across IM Supply Chain, IM Quality, and Therapeutics Development & Supply (TDS). Key responsibilities include managing processes related to budgeting, resource planning, and reporting, while ensuring compliance and driving continuous improvement.

Requirements

Bachelor’s degree required, preferably in Pharmaceuticals, Chemistry, Engineering, Sciences, or a related field.
Proven experience in a regulated industry (pharmaceuticals, medical devices, biotechnology), preferably in Quality Assurance or Quality Engineering.
Experience in supporting or leading audits, NC/CAPA and/or change control activities.
Familiarity with budget and business support activities, including relevant systems and tools.
Strong written and verbal communication skills, with the ability to clearly present quality risks, decisions, and recommendations to cross-functional partners.
Demonstrated ability to manage multiple priorities, work independently, and adapt in a dynamic environment.
Global mindset with collaboration and relationship-building capabilities.
Ability to identify, influence, and implement effective solutions.
Fluency in English is required.

Nice To Haves

Experience in managing internal and external audits, including preparation, participation, and response development.
Knowledge of Business Process Management, Six Sigma, compliance management, and financial planning.
Technologically savvy and data-driven approach.

Responsibilities

Serve as PQM process owner for selected QMS processes, including Internal Audits.
Provide back-up support for other systems such as NC/CAPA, Change Control, Document Management, and Training.
Assume additional ownership of tactical support systems over time (e.g., COMET STAR user), ensuring compliance, system access, and oversight.
Actively participate in councils and forums related to QMS processes.
Continuously improve processes and systems to enhance efficiency and effectiveness.
Support Quality Review Meetings, metrics, and dashboards for PQM and TDS.
Provide budget support for PQM, including headcount oversight, LRFP, and BP planning (currently for PQM-base and ECSQ), in alignment with other team members.
Support onboarding and training of new team members as well as document management and training activities to maintain PQM’s operational continuity.

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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits