Quality Unit Director

**COMPANY**

Polyplus is a leading solutions provider for advanced biologic, cell and gene therapy. We expand from research to commercial scale. Polyplus is an innovator in nucleic acid delivery, and has the legacy portfolio featuring process-centric transfection reagents, kits and related support and services. Headquartered in Europe, the Polyplus team continues to grow globally with operations in the United States and Asia.

**Head Quality is accountable for ensuring the all-time readiness of plant for various GMP compliance audits, being the single point contact on all Quality matters.**

**MISSIONS**
- **Quality Assurance and regulatory affairs Oversee**:_
- Ensuring to develop, implement, manage, audit and maintain GMP and ISO quality systems.
- Ensuring to perform all vendor qualification and compliance audits.
- Ensuring to develop, manage and maintain a GMP compliant document control system.
- Ensuring all non-conformances (deviations, errors etc.) are treated properly and in conformity with the quality system
- Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
- Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.
- Ensuring to Provide quality guidance to product development projects and programs.
- Ensuring to Maintain and improve departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) all validations strategies and external and internal customers, with respect to quality, service, lead time and cost.
- Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose
- operationally and commercially.
- Ensuring that all activities are performed in accordance with GMP, company SOPs and policies.
- Ensuring that there is a self inspection programme in place which is communicated to Operations to meet the requirements of EU GMP/PICS/US regulation/MHRA etc
- Ensuring legislative requirements are adhered to and safeguard the company’s compliance with worldwide regulations / regulations submissions.
- Ensuring the latest updates of regulatory requirements are implemented and available for use and communicated both internally and externally.
- **Quality Control and analytical development oversee**:_
- Ensure the management of all validation activities, including validation strategy and approval of protocols and reports.
- Ensure to Develop, communicate & adhere to best Testing practices to ensure that no non-conforming batch leaves Company premise
- Ensure qualification & maintenance of equipment's, department & premises.
- Ensure optimum utilization of the resources available so as to comply with the agreed timelines with customers, internal & external.
- Ensure - ZERO- down-time for want of maintenance of machines, manpower & material
- Observing and complying with GLP.

**PROFIL & COMPETENCES**
- **Skills**:_
- Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
- Quality professional with 15+ years of hands-on experience with increasing responsibility in a QA function.
- Prior responsibility for Quality Control would be a plus.
- Hands on experience implementing quality systems in a GMP environment, and direct experience with FDA and other health authority inspections. Extensiveknowledge of various GMP compliances regulations and industry practices.
- Ability to critically evaluate and troubleshoot complex problems is essential.
- Strong hands-on leadership and management skills with a - can do
- attitude.
- Ability to effectively participate on multi-disciplinary teams.
- Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
- Good understanding of the pharmaceutical market, including the unlicensed medicines sector.
- Wide knowledge of products and processes used in the manufacture of unlicensed medicines.
- Strategic thinker with the ability to influence at a senior level.
- Highly customer focused. Excellent project management skills.
- Adept at Conflict Management & resolution

**AVANTAGES**
- Join us to participate in the development of innovative therapies to improve the lives of people around the world
- Great working environment with dynamic and qualified teams
- 20 minutes by tram from Strasbourg in the heart of the attractive Illkirch Innovation park.
- A growing company on a human scale where each person can make a differenc