Manager, Plant Engineering, Compliance

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you a passionate leader and a former GxP professional? Do you excel in the management role working with people development and stakeholder interactions?

We have recently started manufacturing in our new production facility, and your management is an important part of a successful operation where you will be joining a diverse team of highly qualified colleagues.

The department:

The Technical Compliance team is part of Plant Engineering covering the areas of manufacturing maintenance, metrology, utility operation, asset management and compliance. We are service-minded and deliver reliable support with a high level of professionalism for the full Copenhagen site.

The Position:

Your team are processing deviations, CAPA, change requests and facilitating systematic problem solving in relation to equipment compliance. You have oversight of the department areas and assist with internal and external audits and regulatory inspections. We are constantly ensuring the compliance is aligned with current standards for GMP production, i.e., EU GMP, 21 CFR and ICH guidelines.

As manager for the Compliance team in Plant Engineering, you will be involved in various daily tasks in a dynamic and challenging environment. Your main responsibility will be supporting across Plant Engineering ensuring compliant documentation, which includes:

• People development, high level of employee engagement and performance
• Close collaboration with internal and external stakeholders
• Oversee and manage handling of Change control, deviation handling and CAPAs.
• Fast follow-up on incident situations including facilitating root cause analysis.
• Ensure compliant and cost-effective service agreements for service contractors.
• Lean leadership and continuous improvement of our processes

Your Profile:

The ideal candidate has 3-5 years of experience as manager or team leader, preferable with experience from a role in QA or GxP support. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology, chemistry or similar.

You are an excellent collaborator and can motivate others. You operate with a strong sense of urgency, see solutions and removes obstacles. You possess good communication skills – including the ability to communicate clearly and professionally in English and Danish both oral and written.

How to apply
Send your application as soon as possible, as we process the applications as we receive them.

If you need further information about the position, please feel free to contact Mathias Broundal, Sr. Director, 45 31720703

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is 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. 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 Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers 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