*Product Quality Manager
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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 working on coordinating 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.
Your 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.
Your qualifications and professional background:
One of the qualifications we are looking for in our new Product Quality Manager is a strong technical background, a focus on high quality, and informal leadership skills. 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. 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)
We will be reviewing and interviewing candidates on an on-going basis, so please apply as soon as possible.
For further information, please contact Ditte Andreasen at [email protected]
For agencies, please contact our Talent Acquisition team at [email protected]
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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.
Information og data
Denne ledige stilling har jobtypen "Kvalitetskoordinator", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 14.6.2022, men kan have været deaktiveret og genaktiveret igen.
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- København
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