Janssen Pharmaceuticals, Inc. is recruiting for a Manager, Quality Systems in Athens, Georgia!

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. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

This role ensures compliance with regulatory requirements and internal company procedures. Provides Quality support to site projects ensuring that all J&J quality standards and global regulatory requirements are being met.

Build and execute activities including early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation.

Provides quality mentorship and support to project and/or base business support team.

This position will review and approve SDLC validation documentation including the approval to release system implementation and/or changes for production use.

Key Responsibilities

• Find opportunities in data, analytics, metrics, reporting and related tool and propose useful insights.
• Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems.
• Optimize data and analytics related tools environment (e.g., BI tool, contents and Tagging management tools, data catalogue).
• Lead strategic use of infrastructure service and platforms for data and analytics.
• Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals.
• Conduct appropriate training as required by Johnson & Johnson Group and Janssen Pharmaceutical employees to follow regulations and compliance.
• Resolves and manages technical and tactical operational problems. Drives innovation within functional area Strong collaboration, interdependent partnering, and influence skills.

• Encourage trust and quickly build credibility.
• Utilize listening skills and incorporates diverse points of view.
• Promotes the business value of diverse perspectives. Influences and persuades. to bring about process and technical improvements.

• Exercise excellent strategic and big picture thinking ability, complemented by operational and business planning orientation.

Qualifications

Required Qualifications:

• A bachelor’s degree in science, Computer Science/Technology or Engineering, Additional certifications a plus.
• 5+ years of Quality Assurance / Quality Systems experience in an FDA-regulated industry (Pharmaceutical, medical device, Biotech).
• Solid understanding and practical application of FDA regulations for pharmaceuticals or medical device.
• Knowledge of ICH Q7 guidelines and ISO 13485.
• Knowledge and skills with IT systems; pharmaceutical industry or other leading industry data analytics, metric reporting, and process analysis tools.
• Strong analytical and statistical skills.
• Experience leading data strategy or transformation in data and analytics.
• Proficiency in skills including, Quality Strategy, Applications and Infrastructure, Data Integrity, Quality Theory, Testing, Quality Management Systems.
• Understanding of a QMS with experience leading entire or parts of a QMS, or equivalent.
• Able to travel up to 10%.

Preferred Qualifications:

• Able to lead multiple initiatives daily while being flexible and adaptable to shifting priorities when needed.
• Ability to apply risk management philosophy to business processes, decisions, and data.
• Knowledge of IT systems; pharmaceutical industry or other leading industry data analytics, metric reporting, and process analysis tools.
• SAP experience a plus.

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 ( http://www.careers.jnj.com ).

#LI-PA1