SQE Manger - QA Complinace

The SQE Manager, QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring accurate and timely completion of associated documentation in support of pharmaceutical production in compliance with all CFR, USP, cGMPs, and SOPs. SQE Manager, QA Compliance will rely on experience and judgment to plan and accomplish goals specific to the Supplier Quality Program. This position supports the ongoing development and manufacture, of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.

Job Responsibilities

· Oversee and Manage Approved and Conditionally Approved Suppliers

· Willingness to travel as needed for Audits of Suppliers

· Enforce and follow Standard Operating Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP)

· Support Supplier Quality Team with coordination of area projects and continuous improvement initiatives

· Ensure timely completion and accuracy of procedural documents related to Supplier Audits, Supplier Complaints, Supplier Qualifications, and Supplier Requalification’s

· Maintain Supplier NDAs and Quality Agreements

· Management and reporting of metrics related to applicable Supplier Quality Program

· Manage, provide guidance and oversight to other members of Supplier Quality Program

· Assist with deviation investigations, CAPAs, Change Controls, and other documents as needed

· Ensure self and direct reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental and company policies

· Perform other duties as assigned

Required Skills:

· Be able to communicate timely and effectively with both senior management and employees

· Ability to hold employees accountable for accurate, complete and timely task execution

· Must display sound judgment, ability to seek guidance, and provide clear directions

· Strong listening, verbal/written communication, achieve accuracy without being rushed, efficient time-management, problem-solving, attention to detail, prioritization, organization, interpersonal, computer and conflict management skills

Education Requirements

BA/BS in Management, Technical or Manufacturing field preferred; Associates required, or a combination of experience and education may be substituted in lieu of a formal degree.

Other requirements:

· Two (3) years previous leadership preferred

· Five (5) years SQE experience in the automotive, pharmaceutical, food or chemical or other cGMP industries required

· Lean/Six Sigma experience preferred

· ASQ CQA accreditation preferred