Senior Quality Systems Specialist
12 hours ago
About AGC Biologics
We are a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way.
Our mission is to work together with our customers to improve patients' lives by bringing new biopharmaceuticals to market. We keep open communication with a focus on professionalism, and we are open-minded and committed to providing high-quality service to our colleagues and customers.
Job Description:
We are seeking a highly skilled Senior Quality Systems Specialist to join our QMS & Training team in the Quality Systems department. As a key member of the team, you will collaborate with partners and drive improvement projects optimizing our GMP Training standards and systems such as our Training Management System, Trainer program, and 'TWI based' Work Instructions program.
You will continuously develop new training standards, courses, and programs to support business needs and goals. To excel in this role, you will need to have an academic degree and substantial training experience, preferably in GMP-regulated environments. You should also have proven experience in planning and successfully executing projects, confidence as a trainer with strong facilitation abilities, and familiarity with eLearning development, particularly in Articulate Rise and Storyline.
A team-oriented and service-minded approach is essential for success in this role. You must be able to build trustful relations with our partners and drive changes via your interpersonal skills. Effective verbal and written communication skills in English, with Danish proficiency as a bonus, are also required.
Requirements:
- An academic degree and substantial training experience, preferably in GMP-regulated environments
- Proven experience in planning and successfully executing projects
- Confidence as a trainer with strong facilitation abilities
- Familiarity with eLearning development, particularly in Articulate Rise and Storyline
- A team-oriented and service-minded approach
- Effective verbal and written communication skills in English, with Danish proficiency as a bonus
- Knowledge of Training within Industries (TWI) and LEAN are advantageous
What You Will Do:
As our new colleague, you will play a central role in enhancing our training standards to improve quality across the company. You will work closely together with partners across all functional areas at the site and globally to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with current GMP.
You will continuously develop new training standards, courses, and programs to support business needs and goals. Our QMS & Training team is part of the Quality Systems department and is an important part of the Quality organization.
About the Team:
The QMS & Training team is responsible for maintenance and development of our Quality Management Systems, including Deviation, CAPA, Change Control, Complaints, Training, and Document Control. The team works closely together with partners across all functional areas at the site and globally to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with current GMP.
Company Overview:
AGC Biologics is a rapidly growing company with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in multiple locations.
Benefits:
We offer a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations, and ordinances.
Location: Copenhagen Site
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