Senior Analyst in Business Process Quality for Johnson & Johnson managing quality processes. Focus on compliance, budgeting, and resource planning in a global healthcare environment.
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.
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.
Preferred: 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.
Benefits
Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees in Colorado – 48 hours per calendar year; for employees in 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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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