Senior Quality Manager - Packaging Manufacturer | Pharma

Senior Quality Manager

Our client, a pharmaceutical packaging and labeling company, has experienced consistent growth in recent years and is now looking to hire a Senior Quality Manager. Serving a customer base that includes clinics and pharmacies, this role offers significant exposure to executive leadership. Reporting directly to the VP of Quality, the Senior Quality Manager will play a key role in high-impact initiatives and collaborate closely with C-Suite executives on upcoming projects.

Job Description

Direct all functions within the Quality and Regulatory departments, ensuring smooth and efficient operations across both executed and pending activities. Facilitate cross-functional collaboration on training programs, SOP development, and inspection readiness to maintain regulatory compliance. Ensure company policies and procedures fully comply with FDA, DEA, and other applicable regulatory agency requirements. Oversee the documentation of new or updated processes into SOPs and ensure appropriate training is provided to all affected personnel. Support the qualification of new equipment, technologies, and systems through the execution of IQ, OQ, and PQ protocols.

Stay current on industry best practices, contributing to the continuous improvement and updating of policies and SOPs. Identify and implement process improvements to drive innovation and increase operational efficiency. Act as a senior leadership team member, offering strategic guidance and contributing to high-level organizational decisions. Lead the execution of product recall activities, ensuring prompt, compliant, and effective resolution. Maintain organizational readiness for external inspections and audits, ensuring ongoing compliance.

Review and analyze compliance data and reports to uphold GMP standards and meet all regulatory expectations. Evaluate audit findings, identify root causes of non-compliance, and present corrective action plans and reports to executive leadership. Actively support continuous improvement initiatives focused on enhancing product quality and production performance. Conduct internal audits to evaluate and verify the effectiveness of quality control systems. Oversee the design, implementation, and maintenance of a comprehensive and effective Quality Management System (QMS). Provide expert support during regulatory inspections, ensuring full demonstration of compliance across all areas. Lead the implementation of corrective and preventive actions (CAPAs), promoting a culture of proactive quality management.

Partner in the integration of digital tools and systems to streamline operations and improve data accuracy and accessibility. Collaborate with executive leadership to prepare for and present monthly Quality Meetings and the Annual Product Review.

The Successful Applicant

5+ years of managerial or supervisory experience. Experience with cGMP and SOPs. Inspection background. Experience dealing with the FDA. IQ / OQ / PQ experience. Background in pharmaceutical, medical device, or food packaging manufacturing. Sponsorship not provided.

What's on Offer

Salary up to $110k depending on experience. BCBS insurance. 2-3 weeks PTO. Discretionary bonus eligibility.