Senior Director, Compliance

3 days ago

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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+

Description

• Ensure the overall cGMP compliance profile is maintained • Develop and implement compliance processes and systems • Establish Global Quality Compliance strategy • Develop and lead inspection readiness programs • Advise on industry issues and regulatory changes • Lead continuous improvement programs • Attract, develop, and retain top talent for Compliance function

Requirements

• Degree in Chemistry, Biotech, or Pharmacy or equivalent • 15+ years of cGMP experience in the pharmaceutical industry • Sterile manufacturing experience and experience leading regulatory inspections required • 10+ years in a leadership role, ideally in a global environment • Experience with regulatory authorities from an auditing perspective in a pharmaceutical GMP environment highly preferred • Experience working with the FDA highly preferred • Knowledge, experience, and skills with quality assurance functions and information technology platforms • Track record of strong involvement with industry professional associations 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 • Capability to collaborate effectively across a global quality network • Listening, negotiating, and effective communication skills under pressure highly preferred • Business minded and customer focused

Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits