Product Quality Specialist

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Résumé du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium, is seeking a Product Quality Specialist to oversee stability management across late-stage to commercial products, based in Belgium, Ireland, Italy, or the Netherlands.

You will lead stability activities, support PQI/PQO/PQL, mentor team members, and collaborate across functions to ensure regulatory readiness and high product quality.

Qualifications

• 6-8 years of industry experience.
• Bachelor’s Degree required.
• Ability to work with others in a team environment.
• 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.

Responsabilités

• 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 independently in the PQS role with minimal support.
• Support departmental goals and activities.
• PQS for Product families that are highly complex or LG 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.

Connaissances

Stability management

Quality Assurance

Regulatory understanding

Team collaboration

Mentor junior staff

Stability SME

Formation

Bachelor’s Degree

Outils

Microsoft Office

Description du poste

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

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 guidanceAbility 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

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 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.