QA Release Responsible Incoming Materials & EU Release

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

QA Release Responsible Incoming Materials & EU Release

Job Description

We are looking for a quality-driven professional who thrives in a dynamic pharmaceutical manufacturing environment and is passionate about ensuring patient safety, product quality and regulatory compliance. You enjoy collaborating with cross-functional teams, building strong partnerships and making sound quality decisions in a fast-paced setting.

At the J&J Innovative Medicines Supply Chain (IM SC) Beerse site, a wide range of pharmaceutical products are manufactured, packaged and distributed worldwide. The Site Quality organization ensures that all GMP-related activities are performed in compliance with applicable regulatory requirements and company standards.

Within the Quality organization, the QA Release team is responsible for the quality oversight and release of incoming materials, including raw materials and packaging materials, as well as supporting EU Batch Release activities for finished medicinal products.

As a QA Release Responsible, you play a critical role in safeguarding product quality and maintaining continuity of supply. You are responsible for the timely and compliant release of raw materials, excipients and packaging materials for manufacturing operations. In addition, you support EU Release activities by ensuring that all quality requirements have been fulfilled before products are certified and released to the market.

You provide quality oversight, assess quality-related events, and collaborate closely with QC, planning,…. Through risk-based decision making and strong stakeholder engagement, you ensure compliance while balancing patient safety and business continuity.

Key Responsibilities

Provide QA oversight for Deviations, CAPAs, Change Controls, Complaints and trend investigations related to incoming materials or batch release activities.

Ensure investigations are conducted in a timely, scientific and compliant manner and effectively address root causes.

Review and approve GMP documentation in accordance with applicable procedures and regulations.

Partner with QC laboratories, Manufacturing, Procurement, Supply Chain and external suppliers to ensure alignment and timely resolution of quality issues.

Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results and act as Quality Point of Contact

Drive continuous improvement initiatives to strengthen quality systems and operational excellence.

Participate in cross-functional governance meetings and represent Quality in project teams.

Support Health Authority inspections and customer audits as a subject matter expert for incoming material release and EU release processes.

Ensure inspection readiness through strong GMP compliance and effective quality oversight.

Promote a proactive quality culture focused on patient safety, compliance and continuous improvement.

Material Release

Review and approve the release of raw materials, excipients and packaging materials for use in manufacturing operations.

Ensure that incoming materials comply with GMP requirements, specifications and regulatory expectations.

Evaluate quality events that may impact material disposition and make scientifically sound, risk-based release decisions.

Ensure timely release of incoming materials to support uninterrupted production schedules.

Act as Quality Point of Contact for incoming material management and release-related activities.

Provide QA oversight for projects involving new materials, suppliers, processes or product launches.

EU Batch Release

Review and approve the release of EU release products as part of the EU Qualified Person (QP) release processes.

Ensure that EU release products comply with GMP requirements, specifications and regulatory expectations

Evaluate quality events that may impact material disposition and make scientifically sound, risk-based release decisions.

Review batch-related quality documentation and assess potential quality impacts on product disposition.

Ensure quality issues with potential impact on product quality, patient safety or compliance are appropriately escalated and resolved.

Provide QA oversight for projects involving EU release processes.

Qualifications

Education

Master's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Engineering or a related scientific discipline.

Experience

Minimum 2 years of experience within the pharmaceutical industry.

Experience within a GMP-regulated environment is required.

Knowledge of EU Batch Release processes and pharmaceutical manufacturing operations is considered a strong asset.

Competencies

Strong analytical and problem-solving skills with the ability to manage complex quality issues.Ability to make risk-based decision under time pressure.

Thorough knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures

Excellent communicator, ability to building a network and create win-win solutions

Understands the business implications regarding quality positions and decisions

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:

€60 000,00 - €96 255,00

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.