Johnson and Johnson

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 https://www.jnj.com

Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Sassenheim, Netherlands, Zwijnaarde, East Flanders, Belgium

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 Director, MSAT Validation & Digital that can be in either Raritan, NJ, Ghent, Belgium, or Sassenheim, Netherlands.

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):

USA - Requisition Number: R-010219

Belgium - Requisition Number: R-012725

Netherlands - Requisition Number: R-012725

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

Purpose:

We are seeking a dynamic and innovative Director, MSAT Validation & Digital to spearhead the development and implementation of advanced strategies for validation, automated processing, and digital data capabilities. The successful candidate will focus on advancing and automating critical compliance functions across Advanced Therapies Supply Chain. This role demands a forward-thinking professional with expertise in validation processes and digital transformation who can drive strategic initiatives that elevate compliance and operational efficiency.

Key Responsibilities:

Strategic Development:

• Lead the design and implementation of advanced validation strategies and frameworks to ensure compliance with regulatory standards.
• Identify opportunities for process automation and digital solutions that enhance validation and compliance functions.

Automation & Digital Integration:

• Develop and deploy automated processing tools to streamline validation workflows, ensuring accuracy and efficiency.
• Collaborate with IT and data management teams to integrate digital capabilities into existing compliance frameworks.

Data Management:

• Establish protocols for data integrity, quality assurance, and validation to support compliance objectives.
• Utilize advanced analytics and data visualization techniques to monitor validation processes and compliance metrics.

Core Competency Development:

• Enhance organizational capabilities in validation and compliance through training, support, and resource development.
• Mentor and develop a team of validation and compliance professionals, fostering a culture of continuous improvement.

Stakeholder Collaboration:

• Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and IT, to align validation activities with overall business goals.
• Communicate effectively with stakeholders at all levels to convey validation strategies, progress, and outcomes.

Regulatory Compliance:

• Stay abreast of industry regulations and standards, ensuring all validation processes align with current requirements.
• Lead inspections and audits related to validation processes to ensure compliance readiness.

Qualifications:

Required:

• Bachelor’s degree in Science, Engineering, Computer Science, or a related field; Master's degree preferred, with 10-12 years of experience.
• Proven experience in validation processes, automation, and digital transformation, preferably within a regulated industry.
• Strong understanding of compliance requirements and regulatory frameworks.
• Proficiency in data analytics tools and automated validation software.
• Excellent project management skills, with the ability to lead and prioritize multiple initiatives.
• Strong analytical and problem-solving skills with attention to detail.
• Exceptional communication and interpersonal skills.

Preferred Skills:

• Familiarity with industry standards such as GMP, GDP, and ISO.
• Experience with programming languages and database management.
• Knowledge of machine learning and advanced data processing techniques.

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 and 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

160,000 TO 276,000 USD Annual

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits 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.

Read Full Description