Director Of Quality Assurance - CMO / CDMO

Title : Director of Quality Assurance CDMO

Location : Greater Boston, MA area

Generous Relocation Assistance provided

Onsite Presence Required

JOB SUMMARY

The Director of Quality Assurance is responsible for managing all aspects of the Quality Assurance while developing, implementing, and maintaining an effective Quality Management System under appropriate regulations and standards. The Director of Quality Assurance is responsible and accountable for all aspects of the Quality Management System (QMS), Supplier Quality, and the Quality Operations Group (QOG). The Director will coach and support personnel in a cGMP manufacturing environment, either as the task holder or through subordinates. Has knowledge and skills across a range of Quality practices, procedures, and principles, with an astute ability to easily rank priorities based on importance and feel comfortable making decisions on quality issues. Manages and supports a variety of processes, including Document Control and Change Control processes. Responsible for material and Finished Goods Disposition and Release. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.

ESSENTIAL JOB FUNCTIONS

• Perform tasks according to Standard Operating Procedures (SOPs), including but not limited to assay and test procedures and Current Good Manufacturing Practices (cGMPs). Stay informed about the information at all times.
• Demonstrate knowledge of and instruct department procedures and company policies, pay attention to detail in all areas, and ensure all the paperwork is completed completely, neatly, and fully.
• Create yearly goals for the group.
• Supervise and guide internal audits of various departments / processes.
• Oversee and perform QA Document Control activities, including processing change requests, manufacturing records, and other documents.
• Write, revise, and review standard operating procedure (SOP)-controlled forms, and related documentation, to maintain best practices and take advantage of current operations.
• Responsible for determining the disposition of all finished and in-process products in compliance with all applicable regulations.
• Addresses observations or recommendations and implements (CAPA) corrective / preventive actions as needed.
• Oversee supplier quality program and suppliers.
• Participate in process improvement teams to offer enhanced expertise and facilitate workflow improvements. Make sure that documentation of improvements is prepared and authorized as necessary.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements per company policy.
• Adhere to company safety requirements. Ensures a safe workplace by establishing and enforcing company safety standards and following legal regulations.

Experience and Skills

BENEFITS

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