Senior Quality Assurance Associate

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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Role Summary:

As a Senior Quality Assurance Associate you act as a primary QA point of contact for the Weighing & Logistics department and ensure GMPcompliant operations. You also provide backup support to Production Units (PU) and support the QA Release team to maintain a timely compliant and reliable product flow within the supply chain.

Key Responsibilities:

Quality Oversight & SME Responsibilities

• Act as the Subject Matter Expert for Weighing & Logistics operations and related quality processes.

• Ensure GMP compliance of all W&L activities including material handling weighing sampling and logistics flows.

• Ensure nonconformances CAPAs change controls and product quality complaints are thoroughly investigated riskassessed timely closed and compliant with internal procedures.

• Ensure issues with potential patient or supply impact are appropriately escalated through defined escalation pathways.

• Review and approve GMP documentation (procedures work instructions protocols reports).

• Provide QA support for production plants when needed (PU coverage and crossfunctional QA support).

• Provide coaching and training to strengthen the quality culture and understanding of cGMP within supported departments.

• Ensure data integrity principles (ALCOA) are applied and maintained across W&L processes.
  

Support to QA Release Activities

• Collaborate closely with QA Release colleagues to support the timely release of commercial APIs.

• Work as one team with QA and Supply Chain partners to enable a reliable supply chain.

• Review and approve APRs and CPV reports for assigned product portfolios.

• Support batch record review and data verification activities when needed to ensure continuity of release activities.
  

Stakeholder Engagement & Compliance

• Build strong partnerships with Business and Quality stakeholders to ensure alignment of objectives and proactive issue resolution.

• Serve as spokesperson for supported areas during Health Authority inspections and customer audits.

• Drive continuous improvement initiatives by identifying opportunities standardizing processes challenging the status quo and implementing solutions that enhance quality and compliance performance.

• Contribute to inspection readiness activities and support audit preparation for W&L and related processes.
  

Standby Responsibility

• Participate in the standby / oncall rotation to support 24/7 manufacturing operations and ensure timely QA decisionmaking outside regular hours.

Experience and Skills

• Masters degree in a scientific field (chemistry pharmaceutical sciences bioengineering ).

• Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance; experience as release responsible is an asset.

• Ability to work independently while staying well connected with stakeholders.

• Excellent analytical skills able to work flexibly under time pressure and make riskbased decisions with business impact in mind.

• Indepth knowledge of cGMP (domestic & international) ICH guidelines policies and quality systems.

• Experience with regulatory inspections and preparedness.

• Demonstrated ability to drive continuous improvement and implement sustainable quality solutions.

• Strong influencing negotiation communication and presentation skills.

• Focused team player with a proactive mindset.

• Experience with SAP MES or other GMP digital systems is an asset.

• Fluent in Dutch and English (spoken & written).

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Preferred Skills: