Description:Key areas of accountability for this role are to provide professional expertise and strong technical leadership in GVP and GCP and applicable regulations and guidance and to identify compliance issues/risks proactively. Contribute to the GVP audit strategy and lead GVP audits. Prepare GVP audit plans and conduct GVP audits. Manage GVP audits led by contractors. Develop and conduct and/or host GVP gap assessment, GVP quality assessments, GVP questionnaires and other QA investigations. Act as GVPQA point of contact for Quality Management System Elements as assigned (e.g. review SOPs, training material, contracts, documentation). Oversee and manage the GVP Deviation and CAPA management process using Veeva. Develop and periodically report Quality Metrics/KQIs. Prepare, review, and approve internal and external reports and other documentation required by regulatory agencies, stakeholders and/or management, to support the quality assurance function.Additional Skills & Qualifications: Minimum Bachelor’s degree in life sciences is required or equivalent. A minimum of 7+ years of GVP auditing experience and a minimum of 10 years in pharmaceutical industry is required.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.About Actalent Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Full-time