Specialist Quality Assurance

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

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.

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About Innovative Medicine

Ourexpertisein Innovative Medicine is informed and inspired by patients whose insights fuel our science-based 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 Overview

The Specialist Quality Assurance acts as a quality expert supporting the implementation and execution of Quality Systems to enable the successful introduction and manufacture of new biotherapeutic products. The role ensures compliance with cGMP global regulatory requirements and company policies by working crossfunctionally with Operations QC Engineering Planning and Development. Through independent judgment and subjectmatter expertise the Specialist QA contributes to a strong quality culture while enabling the consistent delivery of safe compliant and highquality products.

Key Responsibilities:

• Implement and maintain Quality Systems including validation change control batch record review and batch release for new and existing products

• Review prepare and approve GMP documentation such as validation reviews method transfer protocols MES master batch records material master changes and change controls

• Perform batch record review and prepare release documentation for raw materials intermediates and bulk products

• Act as deputy process owner and subject matter expert for raw material release and WCB/DS/DPC release processes

• Ensure quality systems are compliant effective and continuously optimized across the organization

• Serve as a QA representative and subject matter expert during internal and external audits and regulatory inspections

• Deputize for the QA Manager as required including approval of QA documentation and oversight of key quality processes

Requirements:

• Bachelors degree or higher in Biochemistry Biology Pharmacy or a related scientific discipline

• Minimum of 2 years (MSc) or 4 years (BSc) experience in Quality or regulated supply chain operations

• Strong knowledge of biotechnological or pharmaceutical manufacturing and global regulatory guidelines (cGMP ICH FDA EMA)

• Proven analytical problemsolving and riskbased decisionmaking skills with high attention to detail

• Ability to work independently prioritize effectively and manage complex or conflicting stakeholder requirements

• Strong communication influence and collaboration skills in crossfunctional environments

• Fluent in written and spoken English; knowledge of Dutch and experience in vaccines are considered a plus

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Hereswhat you can expect:

• Application review:Wellcarefully review your CV to see how your skills and experience align with the role.

• Getting to know you:Iftheresa good matchyoullbe invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed:We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps:For successful candidates you will need to complete country-specific checks before starting your new guideyouthroughthese.

Finally at the end of the processwellinvite you to share feedback ina short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & to learn more about you and wish you the best of luck in the process!#RPOEMEA

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

Required Skills:

Preferred Skills:

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 locations 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.