Are you passionate about people development and have experience leading process standardization and optimization? Do you get energized by setting direction when it comes to design and implement effective processes while ensuring full compliance with regulatory requirements?
At AGC Biologics we are looking for you who has several years experience in manufacturing and leading teams to effectively standardize and optimize processes and ensuring to be inspection ready at all times. And of course, someone who wants to be part of a team with the mission to improve patients' lives.
About the Role
As manager for Process Compliance and Documentation, you will be responsible to lead a team of 5 specialists within manufacturing processes, documentation and compliance. The team has the responsibility for:
- developing MPR templates, standardized processes and high-level procedures
- ensuring compliant and effective documents, templates, systems and tools
- driving inspection preparation, coordination and timely follow up on any observations
- leading process compliance and quality performance oversight within manufacturing closely with the quality department
- defining the manufacturing process landscape and governance
- trending & reporting on manufacturing quality processes and effectiveness
Your key responsibilities will include,
- Motivating, coaching, leading, and setting direction for your team
- Building and maintaining strong collaboration with your stakeholders
- Acting as Project Manager for standardization and optimization initiatives
- Ensuring that all activities are continuously aligned with manufacturing needs and goals
Qualifications
- You have a Master's degree in Pharmacy, natural sciences or similar
- Several years experience working as people leader or project manager in manufacturing and deep knowledge of the health authorities requirements
- Proven experience defining and implementing standardization and optimization of processes and operational procedures
- Experience in project planning, coordination and implementation
- Excellent English communication skills both written and spoken
- Master basic Microsoft Office 365 applications (Excel, Word, PowerPoint, Forms)
On a personal level, you are able to look at the broader picture, coach and provide guidance to those you lead. You are systematic and a clear communicator and you thrive working autonomous whilst still in close collaboration with our partners. In busy periods, you are able to keep the overview and set direction through aligned priorities.
Join an international and agile organization
At AGC, you will get great opportunities to work with a wide array of tasks and challenges, and you will get experience with our various departments. Furthermore, as we plan projects and tasks together in the team, you will get the opportunity to influence your daily work. AGC offers an informal working environment where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. At AGC, we have a flexible attitude and we help each other reach deadlines as a team.
Contact and application
For any further questions, your are more than welcome to contact María J Prol García at mprol@agcbio.com. Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process the applications as they arrive.
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company's team and approach are tailored to each of its client's needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
