Associate Director, Laboratory Quality Operations

Responsibilities

• Ensures and is ultimately responsible for compliance of laboratory operations within established SOPs, FDA regulations as well as compendial requirements.
• Collaborates with corporate quality functions to ensure site compliance with the company’s Quality Management Systems (QMS).
• Oversees QMS to ensure timely closure of deviations, investigations, corrective actions, etc.
• Conducts thorough root-cause analysis for investigations.
• Implements corrective and preventive actions to eliminate repeat observations.
• Guides, instructs, and coaches members of management in compliance issues.
• Leads regulatory inspections to ensure minimal observations.
• Engages in client audits and client interactions.
• Writes responses to regulatory and client audit reports.
• Develops and implements systems to aid in efficiency and compliance improvements for the site.
• Develops, implements, and maintains internal auditing program.
• Ensures controlled documentation is generated, revised, approved, and maintained per corporate and regulatory agency procedures.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.

Qualifications

• Bachelor’s degree (Chemistry, Biology, Microbiology) required; master’s degree preferred.
• 10-12 years of related experience required, 12+ years preferred.
• 10+ years of pharmaceutical quality experience required.
• 7+ years of management experience required.
• Prior pharmaceutical experience required; prior CDMO experience preferred.
• Prior experience with controlled substance reporting and handling, final product release, major equipment validation, validation protocol review, process validation protocol review and APRs preferred.