Manager, Process & Personnel Qualification Management Expert

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 105,000 - 182,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year

Holiday pay – 13 days per year

Parental Leave – 480 hours per year

Volunteer Leave – 32 hours per year

Job summary

Johnson & Johnson is seeking a Manager, Process & Personnel Qualification Management Expert to drive compliance and quality excellence in the pharmaceutical industry. You will lead process and personnel qualification initiatives, collaborating with the IM OCMO and various business units to ensure GxP alignment.

The role emphasizes data-centric qualification management and transformation, with opportunities to influence global regulatory practices and cross-functional teams across multiple

Qualifications

• Bachelor’s degree in Science or Business required; Master’s preferred.
• Minimum 5 years in a large matrix organization with 5+ years in pharmaceutical/device compliance.
• Strong English communication skills, both written and oral.
• Understanding global regulatory and pharmacovigilance guidelines in life sciences.

Responsibilities

• Lead PV process and training projects including process development, mapping, and qualification/delivery.
• Act as quality partner for IM Office of the Chief Medical Officer, linking business partners with quality governance.
• Manage tasks, timelines and deliverables; address issues and risks; provide progress updates to management.
• Support and implement the digital transformation roadmap toward data-centric content and qualification management.
• Lead or support audits, inspections, and additional meetings as directed.

Skills

Pharmacovigilance

Project Management

Quality Assurance

Process Improvement

Stakeholder Engagement

Education

Bachelor’s degree in Science or Business

Tools

SOP

GxP Systems

ISO 9001

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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):

Belgium R-109382, Switzerland R-109383, United Kingdom R-109384, United States of America R-107418

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function

Quality

Job Sub Function

Business Process Quality

Job Category

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description

We are searching for the best talent for a Manager, Process & Personnel Qualification Management Expert.

Join Johnson & Johnson's Process & Data Management Team! Are you eager to learn, collaborate, and make a positive impact? As a Manager in Process & Personnel Qualification Management, you will drive compliance and quality excellence in the pharmaceutical industry.

Purpose

In this role, you will lead process improvement projects and use the latest digital tools to support the transformation from traditional processes and training into a data centric content and qualification management system.

You Will Be Responsible For

• You will lead Pharmacovigilance (PV) process and training related projects, including process development, mapping, and training development/qualification and delivery.
• You will be a vital quality partner for Innovative Medicines Office of the Chief Medical Officer (IM OCMO), promoting collaboration and serving as a link between business partners, quality groups, and governance. This role ensures that our GxP Quality Framework effectively adapts to both business and regulatory changes in a proactive manner.
• Your ability to manage tasks, timelines, and deliverables will be crucial for achieving successful project outcomes. Additionally, you will address issues, manage risks, and provide timely updates to management and business owners regarding project progress.
• You will support the implementation of our digital transformation roadmap, driving our evolution towards data-centric content and a robust qualification management system.
• You may support or lead additional projects, meetings, audits/inspections, etc. as directed.

Qualifications/Requirements

• Education: At a minimum a Bachelor’s degree in Science or Business is required (Masters degree is preferred).
• Experience: A minimum of 5 years in a medium to large-scale matrix organization, with at least 5 years focused on pharmaceutical/device compliance. Preferred experience includes process design and training design.
• Communication Skills: Exceptional proficiency in both oral and written English communication, with a talent for articulating complex ideas in a clear and effective manner.
• Regulatory Knowledge: Understanding of global (pre)clinical safety and pharmacovigilance compliance regulations and guidelines, coupled with experience in the life sciences industry's regulatory framework.
• Project Management Skills: Demonstrated expertise in managing intricate projects and fostering collaboration among diverse teams and departments.
• Analytical Skills: Keen attention to detail and robust analytical thinking abilities to evaluate business processes and implement improvements.
• Leadership and Networking: Established track record in personal leadership, building relationships, working autonomously, and cultivating an inclusive work atmosphere that values diversity.

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 & 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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Preferred Skills:

Business Process Management (BPM), Business Requirements Analysis, Coaching, Compliance Management, Cross-Functional Collaboration, Data Savvy, Fact-Based Decision Making, ISO 9001, Leverages Information, Process Governance, Process Improvements, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Stakeholder Engagement, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

The anticipated base pay range for this position is :

$105,000.00 - $181,700.00

Additional Description For Pay Transparency

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)).

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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits