Mgr, GMP Compliance

The Manager of GMP Audits will examine and report on the company's compliance with applicable global GMP related regulations, directives and guidelines through system and process related audits. The scope of the work will encompass all GMP related systems for commercial and supplier manufacturing. The Manager will work with all sites worldwide and report to the highest levels of management in the company. In addition to the core auditing program, will also assist with investigations, due diligence assessments, regulatory agency inspection preparation activities, and other quality assurance activities. Provides oversight and training of the Quality Management personnel in all aspects of the Quality Management function. Manages the day-to-day auditing functions of the department and mentors the auditors both internal and external to develop in the profession and to benefit LHP Meets with multi-functional representatives and assures representation of the department on various LHP initiatives. This includes oversight of the QM Liaisons roles and overall departmental goals and objectives. Presents QM concerns to LHP Management, functional areas, and external LHP customers as required. This may include other Leiner organizations. Works in conjunction with the Director and Associate Director to assure coordination of efforts within the department and with external contracted personnel to assure compliance throughout the product development process at LHP. Provides guidance and shares expertise with Leiner personnel in the interpretation of regulations and Good Manufacturing Practices (GMP), Quality Management audit conduct and reporting, training of auditors, preparation for and management of regulatory inspections. Mentor the Quality Management personnel (including external QM contract auditors) to develop in the profession and to benefit LHP. Meets with multi-functional representatives and assures appropriate representation of the department on various LHP initiatives. Presents QM concerns to QMRI Management, functional areas, and external LHP customers as required. Oversees the activities of supplement staff members. This position works in conjunction with the Director of Compliance to assure coordination of efforts within the department and to assure compliance throughout the product development process at LHP.

Bachelors Degree in the Life Sciences with a minimum of 5-10 years for the manager positions in a GMP technical area and QA oversight. Minimum of 5-10 years for the manager positions in a GMP technical area and QA oversight. Knowledgeable in manufacturing and analytical processes and GMP regulatory requirements. Project and Team/contractor supervisory experience of 2 years. ICH Efficacy Guidelines, auditing techniques and governmental regulatory inspection procedures. Able to work both independently and as part of a team, and must possess excellent project management, interpersonal skills. Demonstrated skills to interact with regulatory inspectors, make presentations at investigator meetings, manage-for-cause audits and present findings in a tactful manner Ability to travel 30% globally is required. Direct GMP auditing experience for a global pharmaceutical company is desirable. Knowledgeable in manufacturing and analytical processes and GMP regulatory requirements. Certification or License: CQA or equivalent desirable

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