Commercial Quality Senior Specialist

Johnson & Johnson Innovative Medicine; Szyszkowa; Hybrid; PLN 121,000 - 194,000; Full time

Benefits offered by this job

Annual bonus with set target

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine is seeking a Commercial Quality Senior Specialist for our Distribution Center in Warsaw, Poland. You will partner with Quality and cross-functional teams to ensure processes under the Quality Management System comply with standards and local regulatory requirements.

You will help drive continuous improvement across documentation, training, and supplier-related activities.

Qualifications

• Requires strong knowledge of quality and regulatory requirements.
• Experience in a regulated environment is preferred.
• Ability to implement CAPA and change control processes.

Responsibilities

• Provide Quality support for distribution center activities.
• Support repackaging and relabeling activities and release of products.
• Assist with CAPA, non-conformances and quality investigations.
• Support audits and quality system improvements.
• Collaborate with cross-functional teams to ensure compliance.

Skills

Audit management

Compliance management

Quality management systems

Quality standards

Regulatory environment

Data analysis

Problem solving

Team collaboration

Education

Master’s degree in a relevant discipline

Tools

Microsoft Office Suite

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

We are searching for the best talent for a Commercial Quality Senior Specialist.

Purpose

We are looking for a Commercial Quality Senior Specialist to join our team at the Johnson & Johnson Distribution Center in Warsaw, Poland.

In this role, you will partner with Quality and cross-functional teams to help ensure processes operating under the Quality Management System remain compliant with Johnson & Johnson standards and applicable local regulatory requirements. You will contribute to maintaining and improving quality processes across distribution, storage, repackaging, relabeling, documentation, training, and supplier-related activities.

Working closely with local and global stakeholders, you will help drive compliance, support quality system activities, and contribute to the continuous improvement of quality processes across the Distribution Center.

You will be responsible for

In this role, you will provide Quality support for Distribution Center activities and contribute to the effective operation of the Quality Management System. You will work across multiple quality processes to help ensure products, documentation, and operational activities are managed in accordance with regulatory requirements and company standards.

Key responsibilities include:

• Providing Quality support for activities related to the storage and distribution of medical devices
• Providing Quality support for medical device repackaging and relabeling activities, including release of repacked and relabeled products
• Supporting Environmental Controls, Validation, Calibration, and Maintenance activities
• Managing quality documentation, including document updates, distribution, archiving, periodic reviews, and controlled copies
• Supporting training management activities and quality agreements associated with processes governed by the Quality Management System
• Participating in the implementation of corporate quality standards and procedures, including compliance assessments
• Supporting CAPA, non-conformance, quality investigation, change control, project, supplier qualification, risk management, and quality metric activities in accordance with Quality Management System requirements
• Participating in audit preparation activities and supporting internal and external audits
• Contributing to quality projects, implementation of new digital tools, and continuous improvement initiatives
• Collaborating with local and global Johnson & Johnson departments to support quality and compliance objectives

The role contributes to identifying quality issues, supporting root cause analysis activities, and helping implement corrective and preventive actions that strengthen the effectiveness of the Quality Management System.

Qualifications / Requirements

We are looking for someone who combines quality and compliance knowledge with strong collaboration, organizational, and analytical skills.

Education & Experience

• Master’s degree in a relevant discipline
• Experience in a similar quality, compliance, pharmaceutical, medical device, or regulated environment
• Experience working within a Quality Management System is preferred

Knowledge & Skills

• Knowledge of applicable quality and regulatory requirements
• Understanding of Quality Management Systems and quality processes
• Experience using quality tools and electronic quality systems
• Strong communication skills and ability to work effectively across teams
• Advanced English language skills
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint
• Strong organizational skills, reliability, and attention to detail
• Analytical and interpersonal skills
• Ability to manage priorities effectively and work in a structured manner
• Ability to work collaboratively within a team environment
• Willingness to learn, take initiative, and contribute solutions
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work with both local and global teams, contribute to quality and compliance initiatives, and support products that make a meaningful difference for patients.

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

#LI-Hybrid

Required Skills:

Preferred Skills:

Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment

The anticipated base pay range for this position is:

zł121000,00 - zł194350,00

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
• 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
• service anniversary and recognition awards
• an opportunity to participate in several insurance plans in some location’s eligible dependents

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