Associate Director, Product Quality

Vor 7 Tagen

Mainz, Deutschland Proclinical Vollzeit

Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis with the ability to work remotely from anywhere within Germany. The opening position that is currently available at this company is for an Associate Director focusing on Product Quality. For more information, please get in touch now

**Responsibilities**:

- Recognise risks and collaborate with project teams and shareholders to mitigate risks throughout the clinical development, validation, proposal and launch.
- Produce structured approaches to communication and governance to assist the product quality network.
- Guarantee significant quality risks are raised and suitably mitigated in a timely manner.
- Guide and influence cross-functional teams to outline and efficiently execute product lifecycle procedures and standards.
- Offer a network for product intelligence and guarantee product information is available and approved.
- Other duties may be assigned.

**Key Skills and Requirements**:

- Educated to a degree level in a life science or similar field.
- Demonstrable experience with an advanced degree would be ideal.
- Exhibited ability within FDA or EMA regulated settings as well as with health authority regulations and guidance.
- Knowledge on compliance needs with a comprehension of present international and regional trends in compliance.
- Familiarity with pragmatic execution of cGMP and regulatory guidelines.
- Know-how of compliance needs for manufacturing and testing mRNA or biologics would be ideal.
- Willing to travel for business needs up to 20% of the time both globally and domestically.
- Fluency in the English language.
- Presentation and communication skills both verbally and in writing towards a varied audience.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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