Head of Development & PV QA & QC
Company Overview Our Mission: Lowering Cholesterol with Novel and Combination Medicines. Esperion is passionately committed to developing and commercializing oral, LDL-C lowering therapies for patients with hypercholesterolemia. Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays. Our Quality Philosophy: Quality is in all we do because all we do is for our patients. Esperion's passion for quality is an integral part of our company culture and is embedded in every aspect of the organization. We are committed to applying the highest quality standards to develop and deliver safe, effective pharmaceutical products that significantly improve the quality of life for the patients and clinical trial participants we serve. Head of Development and Pharmacovigilance Quality Assurance & Compliance The Head of Development and Pharmacovigilance Quality Assurance & Compliance leads the pre-clinical, clinical, medical and pharmacovigilance (PV) quality assurance and compliance program covering risk assessment, procedural documents and training, supplier quality oversight and qualification (audits), CAPAs, and regulatory inspections. This role reports to the Vice President of Quality. This is a remote, work-from-home opportunity. Preferred Location: Remote - US Essential Duties and Responsibilities* • Key lead on establishing and leading the Quality and Compliance program for the entire Development and Pharmacovigilance (PV) Organization, ensuring Quality Assurance for the following:
- GCP Clinical Quality Assurance for Clinical Development, Clinical Operations, and Data Management organizations
- GVP Pharmacovigilance (PV) Quality Assurance for Pharmacovigilance/Safety organization
- GLP Quality Assurance for pre-clinical development programs (i.e., GLP and non-GLP, BioA, PK, and Toxicology)
- Ensure departmental oversight of Contract Research Organizations (CROs), and GVP, GVP, GLP vendors and service providers, serve as Quality lead on governance teams, as appropriate
- Demonstrate Quality leadership and expertise while supporting resolution of quality issues, investigations and CAPA, both internally and with vendors
- Ensure Quality and Compliance Leadership on clinical study, medical and PV teams
- Provide and/or support appropriate risk management for key stakeholders to enable critical decisions
- Develop key quality processes, metrics, and indicators to measure, trend manage, and improve key quality attributes as well as strategies and tactics to communicate progress and issue resolution to appropriate internal/external stakeholders
- Work with GCP/GLP/GVP operations to ensure representation at periodic Quality Management Reviews including KPI and QMS performance and trend analyses
- Ensure quality management and oversight of Trial Master File (TMF)
- Oversee quality assurance consultants/contractors performing audit functions on behalf of Esperion
- In collaboration with the Supplier Quality lead, develop and manage the GCP/GLP/GVP internal and external audit programs to meet all US, European and global Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GVP) requirements.
- Oversee audits of CROs and other vendors supporting Esperion pre-clinical development, clinical development/operations, and pharmacovigilance activities to provide assurance that these activities worldwide are conducted in compliance with GCP/GLP/GVP regulations, and the GCP International Conference on Harmonization (ICH)
- Provide oversight of the internal Deviations, Investigations and Corrective and Preventive Action (CAPA) program for GCP/GLP/GVP related activities
- Lead inspection readiness efforts for GCP/GLP/PV for the Development Organization
- Host and lead Sponsor (virtual and/or on-site), regulatory authority GCP, GLP and PV inspections
- Lead preparation and approval of responses to GCP/GLP/GVP inspection findings
- Maintain a current working knowledge of the US and EU GCP/GLP/GVP requirements, ICH GCP Guidelines, industry practices, internal policies and procedures that impact regulatory compliance
- Manage department budget
- Ensure the Development Organizations linkages to business continuity plans, as applicable, within the development, clinical and PV areas
- Must take a collaborative approach to Quality in partnership with Operations within the scope of responsibilities of this role
- Additional duties and responsibilities as assigned Qualifications (Education & Experience)
- Bachelor's Degree in a relevant scientific discipline with a minimum of 8 years of relevant experience in clinical and/or pharmacovigilance quality assurance; or equivalent education and experience required.
- Pharmaceutical industry experience required.
- Experience in pharmaceutical development with a good understanding of the drug development process
- Technical and scientific knowledge to direct quality assurance oversight for clinical supply activities
- Expert knowledgeable in US and EU ICH/GCP, SOPs and local regulatory requirements
- Effective oral and written communication skills
- Team oriented, collaborative style, with an ability to build consensus among both internal and external constituents Apply tot his job
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