About the Role
We are looking for an experienced Quality Assurance Manager with strong GMP expertise and a proven ability to lead a multidisciplinary QA this key leadership role you will be responsible for a broad spectrum of Quality Assurance activities across two manufacturing sites Olst and Weesp dividing your time evenly between them.
You will lead a team of approximately 15 QA professionals covering several essential QA disciplines including Supplier Quality management and Regulatory Compliance addition to these core areas you will guide the team in executing various sitecritical quality activities that support compliant operations robust documentation practices and effective issue resolution.
As the QA Manager you will set direction foster collaboration and ensure that all QA processes under your responsibility operate to the highest standards of compliance and efficiency safeguarding patient safety and supporting Abbotts strong quality reputation.
If you thrive in a dynamic GMP environment enjoy leading diverse QA functions and are motivated by the opportunity to make an impact across multiple sites we would love to meet you.
What Youll Do
Strategic Quality Leadership
- Translate the global / site QA strategy into annual plans for your functional area.
- Set direction for QA activities across both sites ensuring alignment with EHS GMP and regulatory requirements.
- Lead a diverse QA team responsible for multiple sitecritical quality processes ensuring strong coordination consistent execution and effective crossfunctional collaboration across all quality disciplines.
Supplier Quality Oversight
- Lead supplier quality management activities incl. audits quality agreements performance monitoring change notifications and corrective actions.
- Act as QA point of contact for internal suppliers and collaborate on changes quality improvements and issue resolution.
Market Complaint Handling & Product Quality Surveillance
- Oversee the intake assessment investigation and timely resolution of product complaints received from the market.
- Ensure complaints are investigated thoroughly root causes are identified and corrective/preventive actions are implemented and monitored.
- Drive continuous improvement and trend evaluation using complaint data and quality metrics.
Liaison Between Regulatory Affairs & Affiliates
- Act as the QA interface between Regulatory Affairs and global/local affiliates to ensure alignment on product quality regulatory submissions variations and postmarket commitments.
- Ensure timely QA support for regulatory queries market actions safety updates and product information requests.
- Facilitate communication flow between RA affiliates and site QA to maintain compliance and support market continuity
Compliance & Inspection Readiness
- Ensure manufacturing processes meet GMP regulatory customer and internal standards.
- Prepare and host internal/external audits; and drive effective resolution.
- Maintain sitelevel quality oversight to ensure full compliance with all applicable laws and regulations.
Project Management & Continuous Improvement
- Lead or participate in site and crossfunctional projects aimed at improving quality systems processes.
- Promote continuous improvement mindset and quality culture across the QA organization.
Team Leadership
- Manage and develop a QA team of approx. 15 professionals.
- Foster collaboration between QA teams at Olst and Weesp.
- Build strong stakeholder relationships across Abbott sites to share knowledge best practices and insights.
Reporting & Insights
- Provide regular KPI reporting quality performance insights and strategic recommendations to management and stakeholders.
Who You Are (Must-Haves)
- Masters degree in Pharmacy Chemistry Microbiology or related field.
- 10 years experience in the pharmaceutical industry.
- 5 years in a QA leadership or managerial role.
- Solid experience in Supplier Quality GMP operations and audit management.
- Strong analytical leadership and stakeholder management skills.
- Able and willing to work on-site 45 days/week with a weekly 50/50 presence across Olst and Weesp.
What We Offer
- The chance to lead quality activities across two key pharmaceutical sites.
- A role with high impact on product quality and patient safety.
- A collaborative inclusive environment built on Abbotts values: Abbott First One Step Ahead Play to Win and Powered By People.
- Career growth opportunities within a global healthcare leader.
Join Us
If you are an experienced QA Manager who excels in supplier quality and GMP environments and you want to contribute to the production of highquality medicines for patients worldwide wed love to hear from you.
wed love to hear from you.