Manager, Quality Control

Role Summary

Manager, Quality Control is responsible for providing leadership and direction to the Quality Control organization regarding new product introduction for clinical and commercial projects, ensuring high quality and efficiency across all aspects of the role.

Responsibilities

• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Attends, coordinates and presents at internal and external teleconferences pertaining to new product introductions
• Coordinates cross-functional activities to ensure validation timelines stay on target
• Leads and influences peers and colleagues within the scope of their work
• Leads method validation activities for incoming projects, including protocol creation and execution, data tabulation and review, and validation summary report creation and review
• Supports method transfer activities to other sites, including tech transfer memo creation and execution, data tabulation and review, and transfer summary memo creation and review
• Assists with regulatory filings and audits as required
• Writes and revises SOPs in support of the Quality Control organization
• Makes quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs

Qualifications

• Bachelor‚Äôs Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering
• 8+ years of experience in Quality Control
• Familiarity with statistical quality systems, electronic document management, and laboratory information management
• Familiarity with AbbVie Quality Systems, cGMP, and other regulatory requirements
• Strong communication skills, both oral and written

Skills

• Quality systems knowledge
• Cross-functional collaboration
• Documentation and data analysis
• Regulatory compliance

Education

• Bachelor‚Äôs Degree in Physical or Life Sciences, Pharmacy, or Engineering (or related field)

Additional Requirements

• Travel and physical requirements are not specified as essential in the provided description