Primary Packaging Project Lead
We are seeking a highly skilled and experienced Primary Packaging Project Lead to join our team. In this role, you will be responsible for managing primary packaging systems innovation and new products development, as well as coordinating sustaining and life cycle management across all operation sites and contract manufacturing organizations (CMOs).
Key Responsibilities:
* Develop and implement primary packaging systems in line with the company's strategy and objectives.
* Clinical medical devices design and assessment.
* Manage the life cycle of primary packaging systems, including planning, implementation, and documentation.
* Coordinate and support primary packaging systems benchmarking management, competitors' portfolio analysis, and characterization.
* Scout and assess primary packaging materials, components, and technology according to defined priorities.
Requirements:
* Minimum 5 years of experience working in the pharmaceutical/biologics/medical primary packaging industry.
* Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur., and JP standards, Food-contact legislations.
* Knowledge of Good Manufacturing Practice (GMP) and evolving regulatory expectations in the field of primary packaging raw materials, components, and systems.
* Pharmaceutical business experience and familiarity with the competitive landscape of primary packaging development process, regulatory requirements.
* Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures.
* Proven track record in project management/project management certification will be a distinct advantage.
* Fluency in French and English.
What We Offer:
A permanent contract as consultant with an attractive salary package and access to trainings in technical matters and soft skills. Our organization offers a career path for growth and development.