Quality Execution Counsel

Position Summary:

The Quality Execution Counsel is a managing member of the Quality Department to oversee and manage the prompt and effective execution of quality activities. This position supports the Quality Department by helping build the communication infrastructure essential to an effective functioning of the various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering continuous improvement are the key objectives. This challenging, career-altering unique-in-the-industry position offers a non-traditional legal career path that builds on an attorney?s analytical, organizational, time management and investigative skills and introduces the attorney to the fascinating world of fast-paced pharmaceutical manufacturing. The attorney will gain unprecedented access to Company?s senior management and becomes an integral part of building the quality infrastructure in a uniquely Exela?s way.

Job Responsibilities:

• Drafting, editing, and reviewing FDA-issued regulations and Guidance documents, as well as internally developed technical documents, including Standard Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations.
• Aiding members of the Quality Department in developing and implementing efficient and effective means of communicating with both internal and external constituents, and executing those activities, initiatives, and responsibilities.
• Developing and fostering a culture of time and resources consciousness through coaching time management, issue triage and prioritization, and accountability.
• Enabling and mentoring Quality Department members to provide regular updates on the status of the responsibilities of the various sections of the Quality Department.
• Participate in company-wide legal matters as necessary and when requested by company?s General Counsel.

Required Skills

• Exceptional writing and research skills.
• A strong ability to interpret and understand complex and technical documents, such as regulations, statutes, and regulatory guidance documents.
• Excellent problem-solving, analytical, investigative and decision-making skills
• Effective communication and interpersonal skills to mentor and train employees in conducting effective investigations into product/process failures, wiring concise and thorough investigation reports into root causes, and evaluate potential preventative measures
• The ability to manage multiple projects, priorities, and people in a fast-paced environment

Education Experience and Other Requirements:

• A Juris Doctor from an institution accredited by the American Bar Association;
• Five (5) or more years of experience as a trial lawyer; and
• A demonstrated ability to interpret and understand complex legal and regulatory issues, directives, and guidance.
• A proven record of managing a variety of competing resource-intensive obligations.

A strong tie to the Lenoir/Caldwell County community is a huge plus