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 jnj.com.

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Latina, Italy

Job Description:

Johnson & Johnson IM is recruiting for a Manager External Quality Small Molecules, located in Europe.

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, 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 https://www.jnj.com.

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, build healthier communities, and put a balanced 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 resourcefulness to profoundly change the trajectory of health for humanity.

External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners.

In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our small molecule products, specifically focusing on Drug Products, produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do!

Key Responsibilities:

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.

• Provide quality leadership and technical support to ensure effective execution of quality systems at external manufacturing sites

• Handle 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.

• Establish 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; supervise 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 in science, Engineering and Technical subjects.

Experience and Skills:

Required:

• A minimum of 5 years working in a GMP regulated environment.

• Experience with quality support of clinical and commercial manufacturing operations.

• Experience handling quality oversight for pharmaceutical production.

Preferred:

• 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.

• Experience working with external partners.

• Experience with product transfer, new product introduction, parenteral, and/or combination products.

• Proficient in applying process excellence tools and methodologies.

Other:

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

The expected base pay range for this position in Belgium is 79.800 Euro to 137.770 Euro

The expected base pay range for this position in Ireland is 70.100 Euro to 121.210 Euro
The expected base pay range for this position in Italy is 56.100 Euro to 96.945 Euro

 

 

Required Skills:

 

 

Preferred Skills:

Business Alignment, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

  

 

The anticipated base pay range for this position is:

 

 

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

 

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.