Sr. Compliance Manager

Job Description:

The Senior Compliance Manager is responsible for managing the Quality Systems for cGMP and impact on product lifecycle.

Responsibilities:

• Review product Master Batch Records (MBRs) for completeness and content.
• Responsible for standardization of master batch record process steps and adherence of new products to applicable standards.
• Review and approve supporting documents associated with batch production including forms, labeling and specifications for cGMP compliance and accuracy to the product application.
• Review standard operating procedures (SOPs) and work instructions (WINs).  Ensure documents are complete, accurate and compliant with TRC / CFR requirements.
• Collaborate with the Training department to ensure documents are effectively communicated to TRC employees.
• Manage Annual Product Reviews and customer complaint program.
• Manage retain storage and inspections program.
• Train and mentor Compliance personnel.
• Support Quality management as directed.

Qualifications:

• Four year college degree in Engineering, Pharmacy, Chemistry, Biology or related field
• Minimum 8 years’ experience in Quality Assurance with focus on cGMP compliance
• Proven science-based decision making skills
• Must have knowledge of cGMP guidelines, relevant production processes and QC processes
• Proficient with current word processing, spreadsheet, and database software
• Must be detail-oriented and work efficiently
• Strong interpersonal skills and ability to communicate effectively
• Ability to manage multiple priorities

Qualifications

Qualifications:

• Four year college degree in Engineering, Pharmacy, Chemistry, Biology or related field
• Minimum 8 years’ experience in Quality Assurance with focus on cGMP compliance
• Proven science-based decision making skills
• Must have knowledge of cGMP guidelines, relevant production processes and QC processes
• Proficient with current word processing, spreadsheet, and database software
• Must be detail-oriented and work efficiently
• Strong interpersonal skills and ability to communicate effectively
• Ability to manage multiple priorities