Product Quality Specialist
About this role
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:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Beerse, Antwerp, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Little Island, Cork, IrelandJob Description:
We are searching for the best talent for a Product Quality Specialist.
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
Purpose: The Product Quality Specialist, Stability CoE, has end-to-end accountability for the stability management and oversight from Late Stage Development through full commercialization lifecycle for a portfolio of products. Responsibility for product quality related activities with a specific expertise in stability including protocol and report generation. Supporting the work of PQI/PQO and actively contributing to overall smooth functioning of the Stability CoE.
You will be responsible for:
Stability POC for a set of products families (API and Drug Product)
Oversight of Sample management for stability
Author/oversight of stability Protocols and Reports in accordance with global SOPs including sampling strategy
Support audits and filings as appropriate related to stability questions
Responsible for stability Lifecycle management
Supports PQI/PQO and Business Partners with stability related questions
Support temperature excursions, change controls, stability notifications and escalations as applicable.
Maintain stability statements for assigned products.
Partner with Stability Labs as needed to ensure questions are addressed in a timely manner.
Active Member of Stability CoE:
Support departmental goals.
Give input on topics raised in staff meetings to support continued improvement of stability processes.
Qualifications/Requirements:
Bachelor’s degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree is required.
A minimum of 6 years of relevant experience is required
A minimum of 4 years’ experience in the pharmaceutical, biotechnology, or medical device industry is required (post graduate experience and/or education will count towards years of industry experience).
Experience in API and drug product stability and business implications regarding stability decisions is desired.
Understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management is required.
Insight in pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus.
Demonstrated ability to work independently and in a team environment
Relationship building as part of a team is required.
Strong written and oral communication skills with various levels of the organization.
Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with the ability to apply GMP regulations.
Must be flexible to accommodate US, EMEA and AP work schedules when vital, balancing work and personal time
This position may require up to 5-10% domestic and international travel as business demands.
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):
United States - Requisition Number: R-091995
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
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.