AGC Biologics A/S | Product Quality Manager

Are you a network builder with a strong, holistic Quality mindset, and 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 developing department, now looking for a new colleague to join our team.

As part of the team, you will have responsibility for a product portfolio for which you will be expected to maintain a holistic Quality overview, and build strong collaborative relations with the customers and internal stakeholders at many levels. In this capacity, you will not be functioning as specialist, but work closely with specialists in all areas of Quality.

Our main focus is on customers who are applying for or have obtained  commercial market license for their products, for which we aim to serve as close partner on all quality matters. This 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 of product quality.

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:

• Build strong customer relations by acting as single point of contact for quality towards customers.
• Maintain a holistic overview of Product Quality related matters, based on input from the specialists – including a full overview of metrics and challenges related to Quality and Compliance
• Negotiate and maintain Quality Agreements
• Represent Quality in customer specific project teams.
• Ensure consistent and professional communication on quality matters with customers and internal stakeholders.
• Act as facilitator and close collaborator for all internal stakeholders, in daily operations and during audits and inspections
• Identify areas for optimization, and lead or participate in improvement projects.
• Plan, Coordinate and facilitate annual product quality review for commercial customers.

Qualifications

As our new Product Quality Manager, you will influence the organization with your strong Quality mindset, and drive decisions across organizational structure without formal leadership. You have a track record of either project or people management, with minimum 5 years of relevant pharmaceutical or biotech industry experience in a GMP quality department and/or CMC manufacturing. Additionally, a Master (MS) in life sciences.

Your personal competencies should be:

• A strong network builder, with a positive and enthusiastic mindset.
• Ability to influence without formal authority
• A proactive self-starter – able to work independently.
• 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.
• 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 ad will close. We are therefore looking forward to receive your application today!

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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.