Trade Compliance Manager responsible for import/export compliance in the APAC region at Brooks. Collaborating with stakeholders to ensure adherence to trade compliance regulations.
About the role
- Associate Director responsible for overseeing GMP compliance audits in Global Quality Technical and Compliance Team at Animal Health sites. Focused on ensuring regulatory compliance and effective audit program management in the pharmaceutical industry.
Responsibilities
- Perform comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers
- Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits
- Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes
- Maintain an understanding of company policies, procedures, and guidelines
- Maintain awareness of evolving industry and regulatory trends/regulations
- Obtain and maintaining auditor qualification through ongoing training and continuing education programs
- Coordinate with Site Quality leads on audit refusals and postponements
- Lead project initiatives to maintain the effectiveness and efficiency of the audit program
Requirements
- Bachelor Degree in Engineering, Biology, Chemistry or related field
- Minimum of 5-7 years experience of manufacturing, technology, and/or quality experience within an FDA, an/or EU, API, Drug Product, Medical Device or equivalent environment
- Must possess “Subject Matter Expertise” in areas such as Medical Device/Combination products, Biologics, Vaccines, API’s, Non-sterile Drug Products, or Sterile Drug Product manufacturing
- Biologics auditing experience is required
- Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices
- Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines
- Ability to work independently with limited supervision in a virtual-management environment
- Must have the ability to travel globally approximately 25% of the time.
Benefits
- Flexible work arrangements
- Professional development opportunities
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