The Company:
Celonic is a “Pure Play” Biologics Contract Development Manufacturing Organization (CDMO). Celonic’s mission is to help its customers, primarily small to large Biotech Companies, bring life improving and saving drugs effectively and efficiently to the market using innovative, “next generation” bioprocessing technologies. Celonic has a state-of-the-art Development and Innovation Center in Basel, Switzerland (headquarters), and clinical and commercial GMP manufacturing facilities in Heidelberg, Germany. Celonic offers comprehensive services from cell line development, through the development and optimization of production processes, all the way through to clinical and commercial GMP manufacturing of biopharmaceutical active ingredients (antibodies, bispecifics and other complex proteins). At present, more than 500 highly qualified employees work at Celonic's. Due to the expansion of the company,
The Position:
In your role as Team Manager, you will be responsible for the Qualification & Validation Team, both in terms of management and technical matters. You will coordinate the qualification of equipment, plant and (clean) rooms, ensure the optimization of the associated processes, and represent the team during audits and inspections
Your Responsibilities:
- Technical and managerial leadership of the Quality Assurance Qualification & Validation team
- Overall responsibility for the areas of qualification (equipment and premises), Computer System Validation (CSV), data integrity and associated processes within Quality Assurance
- Responsibility for the efficient organization and timely completion of all routine operational QA activities, including SOP reviews and qualification and validation documentation
- Active development and implementation of the FDA readiness strategy within the area of responsibility
- Ensuring and continuously improving quality assurance measures in accordance with regulatory requirements (including EU GMP Annex 11, 21 CFR Part 11, CSA)
- Strategic development of QA processes with a focus on efficiency, compliance and risk minimization
- Establishing and ensuring data integrity standards across all relevant systems and processes
- Providing support with non-conformities, CAPAs and change controls within the area of responsibility
- Representing the area of responsibility during audits and inspections
Job Requirements:
- A degree in Pharmacy, Chemistry, Biotechnology, Engineering or an equivalent qualification
- At least 8 years of professional experience in a GMP-regulated environment
- At least 5 years of management experience in a comparable role
- In-depth expertise in Qualification & Validation (including CSV, process and cleaning validation, and equipment qualification)
- In-depth knowledge of regulatory requirements (in particular FDA 21 CFR Parts 210/211, Part 11, EU GMP Annex 11, Annex 15, CSA)
- Experience in preparing for and supporting FDA inspections (FDA readiness) would be desirable
- Very good understanding of data integrity and risk-based approaches (e.g. GAMP 5, ICH Q9)
- Strong leadership and communication skills
- Team-oriented approach and ability to collaborate across departments
Why Celonic?
- Make a difference by directly impacting patients lives
- Biologics is an attractive, high growth sector with professional development
- Offers a multinational and diverse workplace
- Proud to be a pioneer in “Next Generation” manufacturing technologies
- Family owned: Entrepreneurial, and short communication lines
- Heidelberg is a great place to live, play and work in the center of Europe