Senior Manager QA, Compliance job in Reykjavík, Iceland

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Last Name*

Email*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP)

Location: Iceland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Senior Manager QA, Compliance to join a biotech organisation. This role is on a permanent basis and is located in Reykjavik.

Responsibilities:

Accountable for guaranteeing compliance with all suitable provisions, of the quality management system and the guidelines and standards suitable for their operation.
Monitor, handle, arrange and prioritise the day-to-day actions of the compliance department to guarantee that all linked functions are efficiently deployed.
Produce and converse metrics designed to measure the success of compliance actions.
Assure personnel receive suitable quality system and regulatory training and direction to enable the execution of quality system and regulatory needs.
Assist with the inspection readiness actions for the facility.
You will form targets for the compliance division in line with the site method and acts as required to guarantee delivery of objectives in a timely manner.
Other duties may be assigned.

Key Skills and Requirements:

Educated to a degree level in a pertinent scientific or engineering field such as biology, biochemistry, chemistry, chemical engineering, microbiology, etc.
Demonstrable experience in handling quality assurance and/or quality systems & compliance functions with familiarity in a people management role.
Knowledge of GMP compliance, health Canada, FDA and/or EMA guidelines.
Acquaintance with executing and supervising GMP operations in a plant manufacturing of commercial products is necessary, with PD, and clinical material manufacturing would be ideal.
A background in protein biologics or monoclonal antibody is preferable.
Former involvement with forming and guiding exceptional teams.
Communication skills both verbally and in writing.
Capable of working cross-functionally as well as develop and preserve partner relations.
Leadership skills to carry out difficult decisions in a logical, rational manner.
Capable of working in a management team as well as engage and influence others within an agile setting.
Works well in a team as well as independently.
Able to train others.
Analytical skills.

If you are having difficulty in applying or if you have any questions, please contact Robert Scott on r.scott@proclinical.com

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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