Director Quality

2 dagen geleden

Oss, Nederland Organon Voltijd

For Organon Oss (The Netherlands) we are currently recruiting a:
**Director Quality**

**The position**

As a Director of Quality, you will ensure Organon Oss remains compliant with world-wide regulations and is permanently inspection ready.

You will act as a Management Representative and PRRC for Medical Devices, overseeing Management and Product Quality Reviews, and leading the Quality Project improvement portfolio to ensure business continuity and efficiency improvements. You will lead both global and site-specific improvement initiatives.

You will lead a team of Improvement Engineers, Product Management Review Officers, a Site Lead Auditor, and an office assistant (currently 12 direct reports).

You will be the Deputy Quality Lead and will take responsibility for all Quality Operations activities in absence of the site Quality Head.

**Welcome to our team**

Organon Oss produces, packages and performs the world-wide distribution of a broad portfolio of pharmaceutical products, including tablets, injectables, sustained release polymeric dosage forms. We have staff (Founders) with a diverse background working in the state-of-the-art technical infrastructure in production and lab areas in Oss. We are continuously investing in our Founders and infrastructures as well as improving our processes.

Quality Operations consists of over 200 Founders and supports the product supply and improvement projects through e.g. quality control testing, product release and quality management system oversight.

**Responsibilities**
- Regulatory Compliance:

- Responsible for regulatory inspections and ensure all commitments and reports are submitted timely.
- Coach the Site Lead Auditor in program execution.
- Ensure compliance with ISO 13485 and FDA CFR 820 for relevant devices and combination products.
- Organize management reviews for all devices and combination products.
- Quality Oversight:

- Provide deep insights into the quality status of Organon Oss.
- Direct and engage the Site Leadership Team on necessary GMP improvement programs.
- Act as the formal PRRC as per Article 15 of the Medical Device Regulation (MDR).
- Project Management:

- Manage the Quality Project portfolio at strategic and tactical levels.
- Sponsor and lead strategic projects, ensuring delivery of agreed project results.
- Lead the profit plan process and forecast updates and ensure that improvement projects will result in actual productivity in the profit planning.
- Team Leadership:

- Coach Improvement Engineers, Product Management Review Officers, Site Lead Auditor and office assistant.
- Ensure staff performance and development through training programs and performance management activities.
- Contribute to recruitment and retention of employees in cooperation with HR.
- Significant Investigations:

- Lead investigations for significant quality deviations and coordinate with various departments.
- Prepare for and participate in Quality Review Meetings to make final decisions on actions.
- Continuous Improvement:

- Lead the Quality Project improvement portfolio.
- Initiate, support, and authorize quality improvements.
- Sustain ERP Quality Management and provide support for enhancements in Oss.
- EHS Responsibility:

- Ensure compliance with EHS legislation and company requirements.
- Create safe working conditions and demonstrate personal commitment to safety and environmental friendliness.

**Required Education, Experience & Skills**
- Academic degree in a relevant field.
- At least 10 years of relevant pharmaceutical industry experience with several years of managerial experience.
- Demonstrated experience in leading large, multi-disciplinary Quality teams.
- Broad knowledge of manufacturing, analysis processes, validations and registrations.
- Experience in various dose forms, in particular Sterile and MDCP products.
- Applies Quality as a competitive advantage and able to motivate others to do as well.
- Strong coaching, empowering and people development capabilities.
- Collaborative approach and builds strong interpersonal connections.
- Holistic problem solving & analytical thinking.
- Innovative mindset with a drive for continuous improvement and simplification.
- Business acumen and solution focused approach in delivering outcomes.
- Excellent oral and written communication skills in Dutch and English.

**Preferred Experience & Skills**
- Experience as a Responsible Person (RP) or Qualified Person (QP).
- In-depth knowledge of global regulations. Experience with Medical Devices directives, ISO 13485 and management review processes.

**We offer**

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive and the summary below will give you an idea of what you can expect.
- Competitive salary and a 3% year-end bonus.
- Attractive collective health care insurance package with considerable reduction rates.
- Solid Pension Plan.
- Incentive

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