Manager, GD (Global Development) Quality Management

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 91,000 - 157,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in the United States seeks a Manager in Process & Personnel Qualification Management to drive compliance and quality excellence in pharmaceutical development. You will lead process improvement projects and support a data-centric qualification management system.

You will partner with Global Development, coordinating cross-functional teams, managing timelines and risks, and delivering high-quality results.

Qualifications

• Bachelor’s degree in Science or Business required.
• Masters degree preferred.
• 5+ years in a medium to large-scale matrix organization with at least 5 years in pharmaceutical/device compliance.

Responsibilities

• Lead process and training related projects, including process development, mapping, and training development/qualification and delivery.
• Act as a quality partner for Global Development, promoting collaboration and linking business partners, quality groups, and governance.
• Manage tasks, timelines, and deliverables; address issues, risks, and provide updates to management and owners.
• Support the digital transformation roadmap, advancing data-centric content and qualification management.
• May lead or support additional projects, audits/inspections, and meetings as directed.

Skills

Project management

Regulatory knowledge

Communication (English)

Analytical thinking

Leadership

Cross-functional collaboration

Process improvement

Education

Bachelor's degree in Science or Business

Master's degree preferred

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.

Job Function

Quality

Job Sub Function

Business Process Quality

Job Category

Professional

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Breda, Netherlands, High Wycombe, Buckinghamshire, United Kingdom, Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description

Manager, Process & Personnel Qualification Management Expert

Join Johnson & Johnson's R&D Quality 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. 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.

What You'll Do

• You will lead process and training related projects, including process development, mapping, and training development/qualification and delivery.
• You will be a vital quality partner for Global Development, 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, managing risks, and providing 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 And Required Knowledge

• 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.

Required Skills

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

€79’800.00 - €137’770.00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.