New job PHARMACEUTICAL/BIOTECH JOB OPPORTUNITY: Associate Director of Pharmacovigilance Quality -- Northeast -- SALARY: $130,000-$150,000

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: PHARMACEUTICAL/BIOTECH JOB OPPORTUNITY: Associate Director of Pharmacovigilance Quality -- Northeast -- SALARY: $130,000-$150,000 Andy Ellis posted a job: PHARMACEUTICAL/BIOTECH JOB OPPORTUNITY: Associate Director of Pharmacovigilance Quality -- Northeast -- SALARY: $130,000-$150,000 "JOB SUMMARY: The Associate Director of PV Quality Compliance Management is responsible for managing Quality Assurance program and interacting with professionals responsible for overseeing internal and external global PV activities related to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPVP), GMP, industry standards and regulations. Although this role is primarily an individual contributor, this individual may also share responsibility for technical development of team members and ensuring the quality of deliverables within their purview. JOB RESPONSIBILITIES: - Demonstrates the ability to successfully plan, adjust, manage and optimize all resources (budgets, staff, technology, etc.) for advancement of all goals and objectives. - Demonstrates broad expertise related to understanding the principles and application of quality and regulatory compliance related to GPVP regulated activities. - Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity. - Demonstrates advanced ability to effectively communicate and influence the outcomes of the decision making process. - Displays highly developed organizational leadership qualities. - Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines. - Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GPVP, and quality systems and management. - Helps craft department goals and ensures linkage to individual goals. - Displays highly effective coaching abilities as well as a successful track record of developing junior staff. - Conduct presentations on quality issues, initiatives and projects at cross functional meetings. - Ensures appropriate systems are in place for monitoring global procedures and practices. - Ensures that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements. - May be called upon to act as department head. KEY RESPONSIBILITIES: - Development, implementation, and oversight of quality activities in support of GPVP activities conducted or monitored by the company. These activities include qualification and monitoring of GPVP Service Providers, monitoring internal GPVP quality systems, supporting regulatory inspections, performing duties required of an internal Quality Assurance Unit, and building cross-functional agreements on strategic quality initiatives. - Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements. - Provides Quality insight/feedback to internal departments. This may come in the form of SOP reviews and/or ad-hoc requests. - Development and reporting of compliance metrics related to GPVP activities. - Coaches/mentors staff as a means to ensure performance and professional development. - Establishes/maintains effective cross functional team communications to advance quality activities of the company. - This position requires up to 25% travel. EDUCATION & EXPERIENCE: - Master's degree in a scientific or allied health field and 7+ years of global GPVP work experience, or - Bachelor's Degree in a scientific or allied health field and 10+ years of GPVP work experience. - 5+ years' experience serving in a senior Quality Management role. - Ability to travel 25%. ---all interested applicants please send resumes to andyellis@pellis.com"

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