Sr. Compliance Specialist
AlcamiDurham, North Carolina, United States
Posted August 19, 2025
Full Time
About the Company
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Job Description
The Senior Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements.
Requirements
- Bachelor’s degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master’s degree in related field with 5+ years of related experience, or equivalent educational and work experience.
- Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
- Good written and oral communication skills.
- Good math skills.
- Good computer skills and knowledge of Microsoft Office products.
- Ability to be trained and to mentor.
- Ability to interact well with clients and regulatory agents.
- Ability to interact well with employees at all levels.
- Ability to negotiate.
- Ability to lead audits.
- Ability to act as a consultant.
