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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, 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 Manager, External Quality (Small Molecules)! This position can be performed in Titusville, NJ, Horsham, PA, Athens, GA or Toronto, Ontario CA.

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):

North America- Requisition #R-016448

Canada- Requisition #R-017597

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

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130, 000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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
• Support 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.
• Support 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.
• Support 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 GMP regulated environment.
• Experience with quality support of clinical and commercial manufacturing operations.
• Experience managing quality oversight for 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, and combination products.
• Proficient in applying process excellence tools and methodologies.

Other:

• This role may require up to 25% of domestic & international travel.
• The anticipated salary range for this is expected to be between $100, 000- $173, 500 USD$
• 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 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.

The anticipated base pay range for this position is:

$100, 000- $173, 500

Additional Description for Pay Transparency: