Senior Quality Assurance Manager - Research

Senior Quality Assurance Manager - Research

Bial

Porto, Portugal

The Position

The Senior Quality Assurance Manager - Research acts as the responsible for managing GCP and GVP Quality Management Systems of Research and Development activities in accordance with applicable legal, regulatory and other Quality standard requirements, following the defined guidelines and goals set by the Company. This is a full-time position based at Bial Headquarters in Porto that reports to Director, Quality Assurance Manager - Research.

Duties and Responsibilities

• Manage Annual Audit Programs, since planning until closure and supervise subcontracted auditors of those fields;
• Manage deviations and change controls in QMS;
• Manage periodic reports, ensuring they are performed timely;
• Host Regulatory Inspections;
• Conduct audits according to the competences defined in the approved Qualification Matrix;
• Monitor Annual Budget;
• Prepare and/or verify SOPs, along with other related documentation;
• Verify the conformity of Quality Management Systems with applicable requirements;
• Comply with the Policies, Standards and Procedures in place;
• Collaborate in all department activities, as needed.

Education and Qualifications

• Degree in Health Sciences: Pharmaceutical Sciences, Pharmaceutical Medicine or similar.

Experience

• Previous work experience in GCP and/or GVP.

Skills and Abilities

• Training in Clinical and/or Pharmacovigilance audits;
• Knowledge in Quality and Document Management Systems.
• Strong computer and digital skills;
• Proficiency in English;
• Ability to negotiate, influence and establish networking;
• Good interpersonal and teamwork skills;
• Excellent communication;
• High sense of responsibility, integrity and ethics.

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Portugal      Pre-clinical Research and Development      Quality Assurance      Bial