Qualified Person (QP) - Pharmaceutical Medical Cannabis

Pharmaceutical Medical Cannabis Industry

Job Type:

Full-time

Working Model:

3-4 days onsite required

Company Description:

Our client is truly one of the leading Pharmaceutical medical cannabis producers, distributors and brands globally, and one of the most established operators in the industry today.

Founded in Canada in 2013, the business was one of the first to scale in a federally regulated market and has since become one of the most recognised names in the global cannabis industry. In Canada, they operate across both medical cannabis and consumer cannabis markets, building a strong position across multiple parts of the sector, and are also a publicly traded company.

In Europe, the focus is purely on Pharmaceutical medical cannabis. The company has been active in Germany & EU since 2019 and has continued to grow its presence through compliant production and supply of high-quality medical cannabis products, strong distribution partnerships, and in-market teams focused on developing key territories. They currently employ over 1,000 people globally, with around 50 employees in Germany and Poland. Over the last 6 years, they have built a strong foundation in Europe across all key markets and are now looking to expand their presence in Germany with this key hire.

Role Description:

As our client continues to grow rapidly across Europe, the volume of medicinal cannabis products requiring batch certification and release is increasing significantly. To support this growth, they are now looking to hire an experienced Qualified Person (QP) to join their Quality team in Germany.

This is a key hire for the business, with two main areas of responsibility. Firstly, you will be responsible for the certification and release of medicinal cannabis products, ensuring that all batches meet the necessary GMP standards and regulatory requirements, and in general QP duties.

Secondly, you will work closely with the Head of Quality to support and improve the wider quality function, strengthening quality processes, maintaining regulatory compliance and helping the business manage its increasing operational demands. The Quality team currently has 6 employees, including a junior QP.

The business is looking for a senior quality professional who can take ownership of QP activities while also contributing to the continuous improvement of quality systems and processes across the organisation.

Your Key Responsibilities:

• Contribute to the leadership and engagement of the Quality colleagues on site, including the promotion of all our clients' people processes and policies.
• Release, certification or rejection of finished products for shipment to the customer, pharmacies & wholesalers in the role of Qualified Person.
• Maintain a chronological register of the released batches of finished products.
• Monitoring compliance with the requirements of the Good Manufacturing Practice for medicinal products.
• Monitoring and management of all relevant GMP processes for compliance with current licenses and guidelines.
• Coordination of recalls and other activities following the occurrence of a potential hazard to the patient.
• Ensure that the rules of Good Manufacturing Practice are followed in the testing, development and manufacturing of medicinal products
• Collection, investigation and assessment of information on complaints concerning the manufacturing of finished medicinal products, in particular quality deficiencies and risks. If necessary, provide information to the competent authorities.
• Carrying out self-inspections.
• Management of authority inspections and customer audits.
• Performance of audits in the course of supplier qualification.
• Review and approval of qualification documents for facilities, equipment and rooms.
• Ensuring compliance with the requirements of Medicinal Products Act (AMG), GMP (AMHWV), Medical Cannabis Act (MedCanG) and other applicable legal bases and controlling the responsible persons

Requirements:

• 7+ years’ experience in a quality management role with full QA responsibilities within a GMP environment within Pharma/Biotech
• 3-5+years' experience as a QP/ Qualified Person
• Fluent in German & Ability to communicate in English in a professional environment
• Confident in using the MS Office package.

Bonus Points

• Experience with Narcotics
• Experience with Medical Cannabis
• As well as QA experience, you also have experience in QC or Regulatory Affairs.
• All Legal German Benefits
• Bonus based on performance
• 3-4 days onsite required

We welcome referrals for this position and offer a referral incentive for successful placements. If you know someone who would be a great fit, please feel free to share this opportunity with them.