Associate Director, Cleanroom Operations Lead

4 weeks ago


Akron, Ohio, United States Caliber Sourcing Full time
Job Summary

We are seeking a highly skilled and experienced Associate Director, Cleanroom Operations to join our team. This role will be responsible for leading a team of Senior Managers, Managers, Team Leads, and Material Handlers in ensuring the cleanliness and compliance of our cleanrooms and GMP areas.

The successful candidate will have a strong background in cleanroom operations, quality assurance, and regulatory compliance. They will be responsible for developing and implementing processes and procedures to ensure the highest level of cleanliness and compliance in our cleanrooms and GMP areas.

This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the success of our organization.

Key Responsibilities
  • Lead a team of Senior Managers, Managers, Team Leads, and Material Handlers in ensuring the cleanliness and compliance of our cleanrooms and GMP areas.
  • Develop and implement processes and procedures to ensure the highest level of cleanliness and compliance in our cleanrooms and GMP areas.
  • Ensure compliance with all relevant regulations and standards, including FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, and cGMPs.
  • Collaborate with cross-functional teams to ensure the highest level of cleanliness and compliance in our cleanrooms and GMP areas.
  • Develop and implement training programs to ensure that all team members are aware of and comply with all relevant regulations and standards.
Requirements
  • Bachelor's degree in a relevant field, such as supply chain, engineering, life sciences, or business management.
  • 9+ years of relevant work experience, preferably in a regulated pharmaceutical manufacturing environment.
  • 7+ years of experience in manufacturing and supply chain areas.
  • 8+ years of direct supervisor/personal management experience.
  • Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
  • Advanced knowledge of microbiology and best cleaning practices.
  • Strong knowledge and application of OSHA, DEA, USP, and other applicable WH regulations.
  • Proficiency in ERP systems/WMS applications and analytics tools.
  • Proficiency in system and application use for business operations.
  • Proficiency in MS Office applications.
  • Strong written and verbal communication skills.
  • Intermediate presentation development and delivery skills.


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