Senior Director, Compliance

3 days ago

🇺🇸 United States – Remote

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

+2 more states

🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🌴 South Carolina – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

•The Sr. Director, Compliance will be a valued member of the Global Quality Leadership team •Responsible for maintaining overall cGMP compliance profile •Engage effectively with regulators, particularly at the FDA •Lead continuous improvement programs and support compliance activities at local and global level •Establish a Global Quality Compliance strategy and direction throughout the Compliance organization •Develop and lead inspection readiness programs and provide guidance on compliance related matters •Advise on industry issues and regulatory changes that may affect PSG •Develop and maintain quality assurance and compliance polices and standard operating procedures

Requirements

•Degree in Chemistry, Biotech or Pharmacy or equivalent •15+ years of cGMP experience in the pharmaceutical industry •Sterile manufacturing experience as well as experience leading regulatory inspections •10+ years in a leadership role, ideally in a global environment •Experience with regulatory authorities from an auditing perspective •Regulatory experience in a pharmaceutical GMP environment highly preferred •Experience working FDA is highly preferred •Knowledge, experience, and skills with quality assurance functions •Strong involvement with industry professional associations is preferred •Capability to network within the pharma industry and partner strategically with international regulators •Industry experience in applying predictive analytics and big data/artificial intelligence to create predictive indicators of quality manufacturing

Benefits

•Competitive remuneration •Annual incentive plan bonus •Healthcare •A range of employee benefits