Senior Quality Manager - Packaging Manufacturer | Pharma

My client is a packaging manufacturer for the pharmaceutical industry and is looking for a Senior Quality Manager due to steady growth they've been experiencing as an organization. The Senior Quality Manager will be primarily responsible for ensuring compliance with regulations and documentation and overseeing all quality activities at the facility.

Client Details

Our client, a packager and labeler for the pharmaceutical industry, has been growing steadily over the last few years and have opened up a search to bring on a Senior Quality Manager. Our clients' main customers include clinics and pharmacies. This is an opportunity to have substantial visibility with executive leadership, as this individual will be reporting directly into the VP of Quality and will play a major role in upcoming projects, working directly with C-Suite leadership.

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.

Please apply below, if you're resume looks to fit in with the criteria. From there, Ben Aldrich from Michael Page will reach out in the next 48 hours if deemed a fit!

Profile

• 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

Job Offer

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

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.