Senior Specialist, External Quality

About the role

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Specialist, External Quality (Synthetics) position.

Responsibilities

• Provide quality and technical support to ensure effective execution of quality systems at external manufacturing sites.
• Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans.
• Support the escalation and issue management processes.
• Review and approve quality systems documentation, including batch documentation and product disposition, change controls, manufacturing instructions, quality agreements, specifications, validation documentation, and technical studies.
• Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.
• Build relationships with internal and external partners to meet patient supply requirements.
• Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.
• Support risk management initiatives necessary to improve performance.
• Write and implement quality procedures and work instructions.
• Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments.
• Provide quality oversight for tech transfer and new product introduction activities.
• Support a variety of projects both internally and with external manufacturers.
• Act as a backup to External Quality account owners in support of external manufacturers as needed.

Qualifications

• A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred.
• A minimum of 5 years working in a cGMP regulated environment.
• Experience supporting quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations, cGMP compliance, and non-conformance investigation.
• Ability to work independently in support of a portfolio of products and external manufactures.
• Experience working on cross-functional project teams.
• Strong communication and influencing skills; demonstrates an ability to communicate at all levels of the organization.

Preferred Experience

• Experience working with external partners.
• Experience with product transfer, new product introduction, medical devices, and combination products.
• Proficient in applying process excellence tools and methodologies.

Additional Description

This role may require up to 25% of domestic & international travel.

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.

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