Job Description

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Horsham, Pennsylvania, United States of America, Tampa, Florida, United States of America, Titusville, New Jersey, United States of America

Job Description:

Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, External Quality (Small Molecules)! This position can be performed at Titusville, NJ, Horsham, PA, Athens, GA, or Tampa, FL. 

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 and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

In this position you will provide end to end quality oversight for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:

• Provide quality leadership and technical support to ensure effective execution of quality systems at external manufacturing sites
• Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners
• Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
• Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.
• Monitor quality performance through the development of 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.
• Influence external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.
• Collaborate with external manufacturers to support health authority inspections; monitor and follow-up on associated response and commitments.
• Provide oversight for tech transfer and new product introduction activities.
• Partner with external manufacturers to define the quality strategy through benchmarking and knowledge sharing.
• Lead risk management initiatives necessary to improve performance.

Qualifications:

Education:

• A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred.

Experience and Skills:

Required:

• A minimum of 8 years working in a FDA regulated environment.
• Experience with quality support of clinical and/or commercial manufacturing operations.
• Experience managing quality oversight for pharmaceutical production.
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
• Ability to work independently in support of a portfolio of products and suppliers.
• Ability to quickly process complex information and make critical decisions with limited information.
• Experience working on cross-functional project teams.
• Strong communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization.

Preferred:

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

Other:

• This role may require up to 25% of domestic & international travel.
• 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)).
• This position is eligible to participate in the Company’s long-term incentive program.
• 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
• Work, Personal and Family Time - up to 40 hours per calendar year

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 & 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 contact us via or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

120,000- 207,000 USD$

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.

Job Tags

Permanent employment, Temporary work, Local area, Immediate start,

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