Manager/Associate Director, Clinical Quality Assurance (GCP)

Mô tả công việc

Manager/Associate Director, Clinical Quality AssuranceAlkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our track record for successful drug development is evident from the more than 20 marketed drugs that use our proprietary technologies, and perhaps most clearly exemplified by the five key commercial products propelling our growth. These are products in major disease areas, such as schizophrenia, addiction, and multiple sclerosis.Alkermes is in an exciting phase of growth that few biotechnology companies achieve, with our diversified portfolio of commercial products and an exciting late-stage pipeline. We are moving ahead with global capabilities, an established approach to innovation, world-class manufacturing, financial strength, and our experienced and dedicated people.This position will :Schedule, personally conduct and/or manage external resources, for Global Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPvP) and CFR/Annex Part 11 audits which will support Clinical Development and Pharmacovigilance activities including but not limited to : Develop risk based audit planning focusing on medical care of patients and adherence to protocols and GCPs for global clinical site auditsDevelop risk based audit planning focusing on patient and consumer safety data, efficient case processing, medical review and escalation for global Pharmacovigilance auditsProvide oversight for and participate in audits of clinical and PV vendors, electronic clinical and PV data systems, clinical sites and clinical and PV documents that will be submitted to regulatory authorities Provide oversight for and participate in audits of drug safety, Pharmacovigilance, medical affairs and commercial vendorsProvide management oversight for and participate in Internal Clinical Development, Biometrics, Medical Affairs and Drug Safety Systems AuditsProvide oversight of CQA auditors and contract auditors to develop specific audit plans, review and assess internal and external audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices. Collaborate with the appropriate Clinical Development team in follow-up to clinical site audits to ensure resolution of audit findings in accordance with industry best practices. Provide management oversight and collaborate with the Drug Safety group in follow-up to vendor, specialty pharmacy and partner audits to ensure resolution of audit findings. When indicated collaborate with Clinical Development and Pharmacovigilance in a lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices. Consult with Clinical Development and Drug Safety regarding perceived GCP/GPvP related vendor performance issues and when indicated work with them to develop a corrective action plan. Provide follow-up corrective action with proposed and contracted vendor services.When indicated perform remote vendor audits and provide follow-up as indicated. Assist with the maintenance of tracking systems for all GCP/GPvP audit activity and provide periodic metrics. Provide input to management for new and ongoing systems development. When requested provide global GCP and GPvP training for clinical investigator meetings and internal staff. Assist management in the preparation and conduct of regulatory agency inspections Travel requirement of 35-50%. Minimum Education and Experience Requirements: Requirements include degree in nursing, pharmacy or allied health/science and 7 years (manager) -15 years (Associate Director) pharmaceutical industry experience within the Quality, Regulatory, or Clinical disciplines. Must have experience in global GCP, GPvP and CFR/Annex Part 11 auditing: clinical report, clinical investigational site, clinical vendor and drug safety/PV vendor. Must have a working knowledge of US, International Conference on Harmonization (ICH) and EU GCP, regulations and guidelines. Must have good interpersonal skills and excellent oral and written communication skills. Must have knowledge of clinical safety and clinical trial management systems (e.g. Argus, ARISg, TrialWorks, IMPACT) as well as standard tracking databases (e.g., TrackWise, LIMS). Personal Attributes Needed: Ability to work with cross functional groups, and handle difficult people/situations under pressure. Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees. Ability to work with the management level in CQA's partnering departments. Ability to deal with competing timelines. Ability to work independently and as part of a team. Ability to prioritize work and handle multiple assignments.Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.