Senior Manager QA, Compliance

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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