My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their quality team.
Due to this growth my client is looking for a Senior QA Manager Pharmacovigilance to join their team on a permanent contract based near Lausanne.
The person will have an overview and assessment of GVP activities to ensure robust systems and processes for global Pharmacovigilance activities.
Lead execution of the Global Pharmacovigilance audit program
Lead the maintenance of the Pharmacovigilance Quality Management System including QA support for Pharmacovigilance supplier qualification, risk management, change control, deviations, review of SOPs with ensuring continuous process improvement
Establish robust collaboration with PhV Leaders, including EU-QPPV.
Reviewing key pharmacovigilance documents, e.g. PSMF, reports, and regulatory submissions.
Assist in preparing, coordinating and hosting Inspections/Partner audits in collaboration with the Pharmacovigilance function.
Support the development of the Pharmacovigilance training program in collaboration with Pharmacovigilance group.
Coordinate responses and corrective/preventative actions from deviations, audits and regulatory inspection findings.
Stay abreast of Pharmacovigilance and Safety regulations, EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
Escalate to Global QA Clinical/ Pharmacovigilance Management of internal and external serious non-compliance/deviations in a timely manner.
Provide support for regulatory authority inspections including conducting pre-inspection audits and inspection readiness activities as assigned.
Minimum Bachelor's degree in a science or healthcare related discipline, or similarly conferred degree from a University
3 - 10 years' experience in a pharmaceutical or bio-pharmaceutical company in a PV QA role with a minimum of 2 years’ lead auditor experience performing GVP compliance audits of vendors and business partners.
Ability to travel a minimum of 30%.
Prior GVP I GCP inspection experience preferred.
Thorough knowledge in cGCP and cGVP and global regulatory requirements;
Experience in managing Audit contractors
Strong Interpersonal skills, including organizational sense, rational and autonomy
Strong verbal and written communication skills with well-structured communication and presentation ability;
English fluency written and spoken (the company language);
Results focused which may require negotiating skills and diplomacy,