The Senior QA Manager of Document Control and Training will be responsible for the oversight of the documentation and training programs.

This includes but is not limited to: Standard Operating Procedures (SOPs), Specifications, Document Change Requests (DCRs), Master Batch Records (MBRs), Protocols, Training Curriculum, and Quality Management Systems (QMS).

This individual will work in a detail oriented, compliant manner to ensure the facility operates in alignment with Rising policies, procedures, and cGMPs.

Key Responsibilities:

• The Senior QA Manager of Document Control and Training will be responsible for the oversight of the documentation and training programs.
• This includes but is not limited to: Standard Operating Procedures (SOPs), Specifications, Document Change Requests (DCRs), Master Batch Records (MBRs), Protocols, Training Curriculum, and Quality Management Systems (QMS).
• This individual will work in a detail oriented, compliant manner to ensure the facility operates in alignment with Rising policies, procedures, and cGMPs.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, or related discipline).
• Minimum of 7 years of experience in Quality Assurance, with a focus on documentation management.
• Experience working in the pharmaceutical industry is highly preferred.
• Strong understanding of regulatory requirements (e.g., FDA, cGMP) pertaining to documentation management.
• Proven track record of successfully leading documentation projects and initiatives.
• Excellent communication, leadership, and interpersonal skills.
• Ability to work effectively in a fast-paced environment and manage multiple priorities simultaneously.
• Proficiency in Document Management Systems (DMS), preferably Veeva Vault.
• Certification in Quality Management (e.g., ASQ) is a plus.

Job Type: Full-time

Pay: $60,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift
• Evening shift
• Monday to Friday
• Night shift
• Overnight shift
• Overtime

Work Location: On the road