Director, Quality (Packaging Operations for Manufacturing)

Responsibilities

• Ensures GMP compliance to 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.
• Conducts thorough root-cause analysis for investigations.
• Implements 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.
• Assists 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.
• Develops, implements, and maintains internal auditing program.
• Safeguards controlled documentation is generated, revised, approved, and maintained per corporate and regulatory agency procedures.
• Safeguards timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

• Bachelor’s degree (Chemistry, Biology, Microbiology) required.
• 10+ years of pharmaceutical quality experience required.
• Related experience in other pharmaceutical disciplines will be considered; 5+ years of management experience required.
• Prior experience in packaging sterile manufacturing is required; prior CDMO experience preferred.
• Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 and APRs preferred.
• CDMO operations experience highly preferred, including technical transfer, qualification, validation, trouble shooting, Regulatory and Customer inspections, process scales-up and commercial operations.
• Must have experience in Packaging manufacturing experience across multiple dosage forms and configurations.
• Strong business acumen.
• Strong knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
• Prior pharmaceutical or CDMO experience in technical functions of development or manufacturing.
• Excellent written and verbal communication and presentation skills required.
• Excellent project management, organization skills and ability to effectively multi-task required.
• Excellent problem solving and critical thinking skills required.
• Able to work independently in a fast-paced and dynamic environment.
• Able to build and grow strong customer relationships and ability to influence others.
• Able to develop and manage a high-performance team focused on quality, accountability, and exceeding expectations.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.