Specialist Quality Assurance QA NPD

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 .

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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 & Johnson Janssen Biologics B.V is recruiting for a Specialist Quality Assurance located in Leidem Netherlands

As a Specialist Quality Assurance - QA NPD you will:

Provides QA support to the introduction launch and lifecycle transition of new products to the Leiden manufacturing site. Acts as the primary point of contact for new productrelated quality topics within the site (e.g. development departments clinical teams production facilities and quality control laboratories). Provides Quality oversight to technology transfer method and process qualification PPQ validation and manufacture of API (Biologicals) and/or Drug Substances for clinical studies (Phase IIII) process performance qualification and readiness for routine commercial manufacturing.

Provides independent review and ensures that clear pragmatic and qualitydriven advice is given regarding the state of GMP compliance throughout product introduction scaleup and lifecycle activities. The Specialist Quality Assurance works in close collaboration with other departments (Operations QC Engineering MSAT and Development Departments).

Reports to Sr Manager QA NPD & Launch and works closely with Specialist Quality Assurance and Experienced Specialist Quality Assurance colleagues. Other internal contacts include colleagues at both operational and managerial levels and all departments within the manufacturing site. External contacts include Quality and NonQuality representatives within J&J Supply Chain (JSC) companies.

The responsibilities and the impact YOU will have:

• Participates as Core Team Member in New Product Introduction projects.
• Provides Quality oversight to the introduction of New Products to the site including CTM PPQ and commercial readiness for routine manufacturing.
• Assesses and reviews Quality Investigations and nonconformances supports investigation teams ensures robust root cause analysis and determines product impact and disposition based on GMP and compliance considerations.
• Escalates serious quality compliance and /or GMP incidents to Site or Global Management
• Supports Site and Global escalation meetings as required.
• Provides Quality support for the development of appropriate Corrective and Preventive Actions (CAPAs) and provides Quality approval.
• Ensures that the local NonConformance and CAPA programs are continuously improved through effective trending and knowledge sharing.
• Participates in risk assessments to ensure that compliance quality and patient safety are not jeopardized.
• Coordinates reviews and provides GMP training (e.g. Nonconformances investigation techniques CAPA) to site colleagues to ensure compliance with cGMP and company training requirements.
• Participates in initiatives that foster a strong quality and compliance culture across the organization including GEMBA walks in manufacturing areas and laboratories.
• Reviews and approves document changes and change controls.
• Optimizes existing processes and identifies new opportunities for process and quality monitoring
• On a rotation basis is available 24/7 as QA representative for critical Quality issues.
• Acts as quality SME and supports preparation for and participation during inspections (e.g. FDA EMA) including APR activities and inspection readiness to ensure successful audits.
• Reviews and approves maintenance notifications and work orders as applicable.
• Partners with site colleagues to ensure that all site changes (e.g. production processes equipment systems) are executed in a controlled and systematic manner and comply with cGMP and regulatory requirements.

Additional Duties & Responsibilities Quality Associate:

• Leads and supports the facility in identifying assessing and mitigating compliance risks across the product lifecycle.
• Acts as Quality representative and provides expertise in site and JBV projects to ensure compliance with cGMP and company quality standards.
• Assesses reviews and approves study protocols and reports to ensure that studies (e.g. stability validation analytical method transfer) are executed in a controlled and compliant manner.
• Acts as member of Quality Risk Management and/or root cause investigation sessions.

We would love to hear from YOU if you have the following essential requirements:

• Bachelors degree or higher in Biochemistry Biology Pharmaceutical degree or relevant education.

Minimum experience required for the position:

• Depending on education BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing QA and/or QC)
• Experience in methods such as Process Excellence Co Think or Kepner-Tregoe is recommended.

Other Requirements

• Proven knowledge of the biotechnological/pharmaceutical industry
• Proficiency in English both in word and in writing
• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment.
• Functions independently in a complex environment to make daily judgment to balance business need regulatory requirements and cost efficiency for all Quality decisions. Is required to determine the level of risk magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.
• Broad knowledge of QA systems (i.e. change control deviation management cGMP validation) manufacturing and laboratory processes facilities and utilities and technical automation.
• Problem solving and troubleshooting to initiate fresh innovative and compliant solutions to manage unexpected quality issues.
• Ability to drive collaboration in a fast-paced environment
• Has good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints.
• Empowered professional who can make well motivated pragmatic decisions on their own.

The anticipated base pay range for this position is 53500.00 to 85445.00 on an annual basis and includes 8% holiday allowance.

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.

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