Senior Manager, Quality Operations

Responsibilities

• Ensures compliance with regulatory requirements and Company procedures.
• Collaborates with corporate quality functions to ensure site compliance with the company’s Quality Management Systems (QMS).
• Collaborates with site Operations and Technical leadership to ensure timely closure of deviations, non-conformance investigations, corrective actions, and other Quality documents.
• Provides oversight to ensure thorough root-cause analysis for investigations.
• Supports implementation of corrective and preventive actions to eliminate repeat observations.
• Guides, instructs, and coaches members of management in quality and compliance issues.
• Provides direct support and leadership during site regulatory inspections to ensure minimal observations.
• Engages in client audits and client interactions.
• Aids in driving on-time site responses to regulatory and client audit reports and provides direct oversight on commitments and content.
• Develops and implements systems to aid in efficiency and compliance improvements for the site.
• Develops short and long-range goals and objectives for the site quality function.
• Supports the Compliance team to maintain the on-time execution of scheduled internal audits and routine supplier management, 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 and a minimum of 10+ years of related experience required.
• A minimum of 7 years of supervisory experience is required.
• Prior GMP experience is required; prior CDMO experience preferred.
• Prior experience with GMP warehousing equipment validation, validation protocol review, 21 CFR Part 210 and 211. ISO17025 experience desired.
• Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
• Knowledge of quality systems and processes, change control, CAPA and data integrity required.
• Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s).
• Knowledge of auditing preferred.
• Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.