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Senior Associate Director, GLP Quality Assurance

Company: CTI Education Group
Location: Ridgefield
Posted on: February 25, 2021

Job Description:

Job Description - Senior Associate Director, GLP Quality Assurance (208893) Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities. Senior Associate Director, GLP Quality Assurance - 208893 Description: Plan, organize, and direct regulatory activities in defined area(s) of pharmaceutical regulatory compliance in R&D. Establish and maintain systems that are compliant with current regulatory requirements. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities:

  • Establish policies and procedures for compliance evaluation of GLP FDA-regulated activities in GLP area of responsibility within R&D; Investigate and resolve compliance issues noted during audits/inspections
  • Act as host for regulatory agency inspections (FDA, EMEA, etc.) in area of responsibility
  • Develop and manage GLP programs designed to enhance regulatory compliance of GLP Quality System and foster an environment for Quality & Records Management (Q&RM) personnel to initiate improvements
  • Develop and manage direct reports within the Q&RM--team
  • Participate in meetings between QA and R&D technical departments to ensure an interdepartmental team approach in the development of compliance policies and procedures at R&D
  • Initiate work-efficiency programs to allow workloads to be competently and efficiently handled by staff
  • Monitor and appraise the performance of direct reports, provide necessary training where required, and maintain effective communication within area of responsibility
  • Foster effective and constructive communication and interaction with client departments; Encourage direct reports in effective communication with client departments
  • Identify areas of potential process improvement related to compliance and take appropriate actions to achieve the improvements
  • Contribute to international Boehringer Ingelheim (BI) harmonization activities in R&D Requirements:
    • Master's Degree with 8+ years in Pharma industry or Bachelor's Degree 10+ years Pharma
    • Prior management of direct reports required
    • Thorough knowledge of Preclinical Development activities (GLP, GCP, USDA, EMEA, OECD)
    • Excellent written, oral communication and inter-personal skills
    • Excellent conflict resolution and negotiation skills
    • Excellent leadership and mentoring skills
    • Familiarity with working in a multi-cultural environment. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older Who We Are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance.--We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture.--Learning and development for all employees is key because your growth is our growth. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc.--is an equal opportunity and affirmative action employer committed to a culturally diverse workforce.--All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

Keywords: CTI Education Group, New York , Senior Associate Director, GLP Quality Assurance, Executive , Ridgefield, New York

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