QA New Product Introduction Responsible

Description

The company works on healthcare innovation across medicines and medical technology, with the aim of preventing, treating and curing complex diseases.

The Quality Department at the Beerse site in Belgium supports all GMP activities for manufacturing, packaging, labeling, testing, release and distribution of products made on the campus.

This QA Specialist role in New Product Introduction (NPI) is part of the Quality organisation in Quality Assurance, Professional category. You will give QA oversight to NPI, product transfers and implementation projects in Device Assembly and Parenteral Packaging, working with Manufacturing, Technical Operations, Engineering, Validation, Regulatory Affairs, Supply Chain and Quality so that new products and processes meet GMP, quality standards and regulatory expectations from the start.

Responsibilities

• Act as the QA representative and main quality contact for NPI, product transfer and implementation projects.
• Oversee the full NPI lifecycle and confirm alignment with GMP, the Quality Management System and applicable regulations.
• Build quality requirements into project plans, processes and deliverables early on.
• Give QA input on the design, development and implementation of new or changed manufacturing and packaging processes, equipment and technologies.
• Review and approve GMP documents, such as risk assessments, protocols, reports, procedures and other project documentation.
• Apply Quality Risk Management throughout projects so product quality, patient safety and compliance risks are mitigated.
• Provide quality and compliance input on deviations, CAPAs and change controls, making sure investigations are sound and closed on time.
• Assess how project changes affect product quality, the validated state, regulatory requirements and GMP compliance.
• Support the handover of new products and processes from project phase into routine commercial manufacturing.
• Support and represent Quality during Health Authority inspections, internal audits and customer audits.
• Drive continuous improvement and lessons-learned work across NPI programmes.
• Ensure NPI batches are released by QA on time to support launch and market supply.
• Provide QA oversight through regular shop floor walkthroughs and by witnessing critical operations.

Requirements

• You combine solid GMP and Quality knowledge with the ability to work well across project teams and manufacturing sites.
• A university degree in Pharmaceutical Sciences, Chemical Sciences, Biological Sciences, Engineering or another relevant scientific field.
• A minimum of 2, 5 years of experience in the pharmaceutical industry.
• Experience in GMP-regulated pharmaceutical manufacturing.
• A quality mindset with attention to detail and accuracy.
• Experience working independently while engaging stakeholders consistently.
• Experience across cross-functional teams and project environments.
• Experience making risk-based decisions in a dynamic, fast-moving setting.
• Familiarity with Quality Risk Management principles.
• Strong analytical and problem-solving skills.
• A drive for continuous improvement.
• Knowledge of pharmaceutical legislation, cGMP regulations, ICH guidelines, policies and procedures.
• Strong communication, influencing and networking skills.
• An understanding of how quality decisions affect the business.
• Fluent Dutch and English, spoken and written.
• An understanding of AI concepts and frameworks, including responsible and ethical AI practice, and the ability to use effective prompting to work more efficiently.
• Preferred: 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).

Conditions

Hybrid role based in Beerse, Belgium, with Antwerp also listed as a job posting location.

Anticipated base pay range is €72 500,00 to €115 230,00.

Equal opportunity employer welcoming applications from qualified candidates of all backgrounds.

Benefits

• An annual bonus with a set target as a percentage of pay, depending on grade and location, based on the employee's and company's performance in the previous calendar year, or sales commissions.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave and volunteer leave.
• Well-being reimbursement and programmes for financial, physical and mental health.
• Service anniversary and recognition awards.
• Insurance plans, subject to plan terms, with eligible dependents in some locations.
• Amounts and benefits may vary by location and may change; this information is for guidance only.
• A collaborative setting that encourages learning, innovation and professional development, with the chance to work across manufacturing, quality, engineering, validation and regulatory functions.