Product Quality Specialist

Posted Yesterday
Be an Early Applicant
4 Locations
In-Office
49K-115K Annually
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Manages end-to-end stability oversight and product quality activities across the medicine lifecycle. Develops stability protocols and reports, manages temperature excursions and change controls, supports regulatory filings and escalations, and serves as a stability subject-matter expert. The role works independently on complex, high-value product families, collaborates cross-functionally, identifies improvements, and mentors less experienced team members.
Summary Generated by Built In

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.

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:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Little Island, Cork, Ireland

Job Description:

We are searching for the best talent for a Product Quality Specialist to be based in Belgium, Netherlands, Ireland, or Italy.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine 

You will be responsible for:

  • Has end-to-end accountability for the stability management and oversight from late stage development through full commercial lifecycle for a portfolio of products.

  • Responsible for product quality related activities with a specific expertise in stability.

  • Supporting the work of PQI/PQO/PQL and actively contributing to overall smooth functioning of the Stability CoE

  • Be expert in specific areas of stability management

  • Operate independent in the PQS role with minimal support

  • Support departmental goals and activities

  • PQS for Product families that are highly complex or L&G of high value requiring interactions with multiple functions and teams.

  • Identify opportunities for improvement

  • Mentor less seasoned members of CoE

  • Participate in cross-functional meetings as needed

  • Support stability related escalations as needed

  • Support regulatory filings with stability information/data.

  • Responsible for stability Protocols/reports

  • Stability SME for assigned product, manage temp excursions, CC etc.

Qualifications/Requirements:

  • 6-8 years of industry experience

  • Education Bachelor’s Degree

  • Ability to work with others in a team environment

  • Ability to manage individual assignments with minimal guidance

  • Ability to read and interpret documents such as SOPs, work instructions, protocols

  • Clear knowledge of stability related regs

  • Proficient with using Microsoft office applications and web-based collaborative applications



Required Skills:



Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

  


The anticipated pay range for this position, in the primary posting location, is:



The anticipated pay ranges for additional locations are:


[Belgium] - The anticipated base pay for this position is 72,500 - 115,230 EUR.
[Ireland] - The anticipated base pay for this position is 63,300 - 101,315 EUR.
[Italy] - The anticipated base pay for this position is 48,600 - 77,395 EUR.
[Netherlands] - The anticipated base pay for this position is 64,000 - 103,040 EUR on an annual basis and includes 8% holiday allowance.

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.



Skills Required

  • 6-8 years of industry experience
  • Bachelor's degree
  • Ability to work with others in a team environment
  • Ability to manage individual assignments with minimal guidance
  • Ability to read and interpret SOPs, work instructions, and protocols
  • Clear knowledge of stability-related regulations
  • Proficiency with Microsoft Office applications and web-based collaborative applications
  • Business alignment
  • Business savvy
  • Coaching
  • Communication
  • Compliance management
  • Continuous improvement
  • Fact-based decision making
  • Human-centered design
  • ISO 9001
  • Issue escalation
  • Problem solving
  • Quality control
  • Quality management systems
  • Quality standards
  • Regulatory environment
  • Standard operating procedures

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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