Senior Quality Manager

Senior Quality Manager

Our client, a packaging and labeling expert for the pharmaceutical sector, has experienced consistent growth recently and is now seeking to hire a Senior Quality Manager. Their primary customers include clinics and pharmacies.

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.

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.

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

Contact : Thomas Graf

Quote job ref : JN-082025-6820468