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Product Quality Manager

AGC Biologics



Copenhagen, Denmark

If you thrive on managing quality activities and customer relations, and are looking for a job where your contribution has a direct impact on our growing success, then we have the perfect job for you.
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

About the job
Product Quality Management is a newly established department, now looking for a new colleague to join our team.

As part of the team, you will be managing essential quality activities. Since the department is new, you will have the chance to influence how we will work via small improvement projects.

We aim to serve as one point of contact for quality matters, which involves maintaining good customer relations, understanding the customer’s quality needs, and collaborating with internal stakeholders and specialists on driving quality activities and maintaining the overview.

You will be based in Søborg, at our largest site in Europe.

Responsibilities
As Product Quality Manager your responsibilities will be to manage the product quality for assigned customers. This includes:

  • Act as single point of contact for quality across departments and sites, towards customers and internal stakeholders
  • Ensure coordination and full overview and progression of quality events, and issues related to quality and compliance
  • Manage quality strategy
  • Create overview and track status of audit findings and mitigations/closure
  • Maintain overview of and prepare input to the quality parts of documentation for the authorities / regulatory filings
  • Manage annual quality review for commercial customers
  • Manage product life cycle
  • Represent Quality in the core project team, acting as partner for the project manager
  • Cultivate consistent and effective communication on quality matters, building cooperation and trust with client.

Qualifications
One of the main qualifications we are looking for in our new Product Quality Manager is leadership skills, with a strong technical background, and a focus on high quality. We expect you to have minimum of 5 years of relevant pharmaceutical or biotech industry experience in a GMP quality department and/or CMC manufacturing, with a track record of either project or people management. Additionally, a Master (MS) in life sciences.

Your personal competencies should be:

  • A proactive self-starter – able to work independently.
  • A strong collaborator with a positive and enthusiastic mindset.
  • Structured approach to tasks, with the ability to prioritize and organize work assignments, independently as well as in teams
  • Thrive in a diverse working environment.
  • Ability to influence without formal authority
  • Excellent communications skills in English (verbal, written, and presentation skills)

Interested?
We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. We are therefore looking forward to receive your application today!

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

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.

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AGC Biologics - hurtigt overblik


AGC Biologics
AGC Biologics
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial production, using mammalian and microbial production systems.

Placering
Vandtaarnsvej 83B
2860 Søborg
Logo: AGC Biologics
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