Manager Product Quality Vigilance Investigation Support

Janssen Pharmaceutical Companies, part of the Johnson & Johnson family of companies, is currently hiring for a Manager, Product Quality Vigilance Investigation Support. This position can be based in Horsham, PA, Raritan, NJ, Vacaville, CA, Schaffhausen, Turnhoutseweg, Titusville, NJ, Borgo San Michele, and Guarabo. Additionally, remote work options may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.

This position will have global responsibility to collaborate with all functions and segments that interact with the global complaint process. By using complaints data, we can uncover unmet needs of our patients through investigative techniques. By partnering globally, we can identify key areas of product improvement and innovation. We believe that experience crafting a stream-lined process, digital technology solutions, innovative ways of working, intellectual curiosity, and leading direct / indirect teams are important to enable you to be successful.

Key Responsibilities:

• Provide support in execution of complaint investigation processes and product quality vigilance systems.
• Responsible to manage overall product quality complaint investigations for products across the Janssen product portfolio when customers require information and follow up.
• Monitor the product quality vigilance investigation process for continuous improvement and measure key process indicators to assess the health of the product quality vigilance investigation process.
• Responsible to actively develop and sustain partnerships with manufacturing and packaging sites, GMS, process users, business owners, Product (Quality) Management, J&J affiliates and external organizations to insure harmonized and consistent product quality vigilance investigation practices and understand the needs for future improvements.
• Participate on global project teams; support development, effective implementation, and continual maintenance and ensure compliance is achieved and standards are met.
• Represent pharma product quality vigilance processes to the regulatory agencies related to investigation requirements and support regulatory inspections.
• Responsible to ensure audit readiness of global product quality vigilance investigation team for products across the Janssen product portfolio.
• Lead, manage, and coach a globally dispersed team of professionals supporting product quality vigilance investigations for products across the Janssen product portfolio.
• Ensure alignment of department objectives and activities with the Global Business Quality Organization and Enterprise Quality System strategic objectives.
• Responsible that each staff member has clearly established goals and objectives, monitor staff performance, conduct periodic performance evaluations and salary planning.
• Ensure succession planning for key positions.

Qualifications:

Education:

• Minimum of a Bachelor’s Degree in a technical, scientific, engineering, or business analytics field, or equivalent
• Master’s or advanced degree in related fields is a plus

Experience and Skills:

Required:

• A minimum of 8 years of related experience, including experience working in pharmaceutical, medical device or other related or regulated industry with prior experience with completion of manufacturing/packaging investigation and/or MDR process (in Medical Device and/or Pharmaceutical Sector).
• A minimum of 2 years of Complaints Management, Post Market Vigilance, Risk Management, or Compliance experience required, including the management of investigations.
• Ability to effectively communicate verbally and in writing (technical and persuasive)
• Experience managing professional level associates

Preferred:

• Advanced Quality Engineering knowledge
• Understanding of Pharmaceutical, Medicinal, Device Products, and can connect the dots to the product lifecycle and complaint data
• Experience with one or more technologies supporting Quality Systems (i.e., complaints).
• Ability to present to multiple levels within the organization

Other:

• Fluency in English is mandatory
• This position may require up to 5-10% travel domestically and internationally.
• The salary for this position, within the United States, is anticipated to be between $100,000 to $155,000

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.