Reporting to the Director of Compliance and based out of the Foster City office you will be responsible for leading the pharmacovigilance audit program, including internal process audits and external vendor audits and you will coordinate audit follow-up and corrective action planning.
You will maintain knowledge of pharmacovigilance regulations and company standard operating procedures for pharmacovigilance. You will ensure the completion of pharmacovigilance annual audit plans. The Compliance Manager will establish excellent working relationships with stakeholders in assigned departments and compliance/quality groups of vendors or business partners. From time to time you will be expected to assist with activities for other GxP compliance programmes, and as such you will be required to develop knowledge in these areas.
You will be responsible for providing guidance on interpretation and application of existing and new regulatory requirements to Regulatory Compliance management and assigned departments. You will assist with the provision of guidance and training to Regulatory Compliance, developing standard training modules on special topics. You will assist in the evaluation of SOPs and processes needed to comply with regulatory requirements. You will provide guidance to assigned departments and management when specific compliance issues arise. You will assist with the preparation, facilitation and follow-up of regulatory authority inspections.
The successful individual will foster a commitment to quality in individuals and a culture of quality within the organization. It is required that work is performed with little to no immediate supervision. This person will evaluate new tools as fit for purpose, they will coordinate and review the work of others. They will manage, lead or participate in various types of audits or projects involving multiple sites.
You will establish relationships and agreements with consultant auditors. You will both direct and collaborate with internal and external staff in the conduct of audits. You will be required to both lead and participate in intra- or interdepartmental teams of an operational nature such as: preparing the Company for changes in regulations, continuous improvement initiatives etc. You will initiate operational change where required and communicate change in a positive manner.
10+ years of relevant experience and a BS.
8+ years of relevant experience and an MS.
Relevant work experience consists of working in a pharmaceutical quality control, quality assurance or compliance environment.
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