Sr Director, Compliance Job at Thermo Fisher Scientific, Washington DC

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  • Thermo Fisher Scientific
  • Washington DC

Job Description

Join to apply for the Sr Director, Compliance role at Thermo Fisher Scientific We are seeking a highly qualified Senior Director, Compliance to join our Global Quality Leadership team, reporting to the Vice President, Global Quality, Regulatory and EHS. This role is crucial in maintaining our cGMP compliance profile through the development and implementation of compliance processes aligned with global quality systems, corporate standards, and regulatory requirements. Key Responsibilities: Establish and lead a global quality compliance strategy and inspection readiness programs. Ensure continuous improvement of quality systems and compliance with national and international cGMP standards. Develop and maintain quality assurance policies and SOPs, and respond to regulatory changes. Lead efforts to ensure compliance with all applicable regulations and maintain robust quality systems. Drive a quality culture that delivers safe and effective products, achieving regulatory excellence. Attract, develop, and retain top compliance talent, and oversee the oversight mechanisms for compliance status. Qualifications: Degree in Chemistry, Biotech, Pharmacy, or related field. 15+ years of cGMP experience in the pharmaceutical industry, including sterile manufacturing and regulatory inspections. 10+ years in leadership roles, preferably in a global environment. Experience with FDA and other regulatory authorities, and a strong network within the pharma industry. Competencies: Knowledge of quality assurance functions, IT platforms, predictive analytics, and big data applications in manufacturing quality. Strong communication, negotiation, and strategic partnering skills are highly desirable. Benefits: Competitive salary, annual bonus, healthcare, and career development opportunities within an innovative organization committed to integrity, involvement, and innovation. #J-18808-Ljbffr Thermo Fisher Scientific

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