Sr. Director - Quality, Concord

Eli Lilly and Company•Concord, NC

11d•$172,500 - $253,000•Onsite

About The Position

The Site Quality Leader is primarily responsible for overseeing the execution of the Quality Management System. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. He/she effectively influences the leadership on strategic direction and tactical implementation of the quality system. The individual in this role establishes the site’s quality objectives, priorities, and roadmap. He/she leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. This may include new facility delivery or existing facility expansion/recapitalization. He/she will also provide quality support for achieving key business objectives. The Senior Director, QA, determines and manages the work agenda and budget for the team. He/she provides leadership and direction in managing product-related quality matters, assuring the independence of the quality unit, while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use and comply with US and international regulatory requirements. The Senior Director, QA, leads and responds to regulatory agency inspections and inquiries. He/she reviews/approves GMP documentation including procedures, training, master production records, technical protocols and reports, change proposals, deviations, and corrective/preventive actions. The Quality Senior Director is responsible for the productivity, tracked through metrics, and the development/enhancement of the department’s staff using the performance management process. The individual in this position will be responsible for quality oversight for parenteral drug product manufacturing, device assembly, and/or packaging, as well as other Quality support functions.

Requirements

Quality oversight for parenteral drug product manufacturing, device assembly, and/or packaging, as well as other Quality support functions.
Stay true to Lilly’s values of Integrity, Excellence and Respect of People.
Ensure employees are trained & understand "Red Book" ethics and compliance.
Ensure a safe and healthy work environment.
Get strong participation from the Q team to HSE program.
Monitor, verify, evaluate, and drive improvement towards site goals.
Ensure staff is qualified, that the initial & continuous training/ GMP education of all personnel is carried out as needed.
Develop people capability & knowledge (technical expertise, behavioral & managerial).
Ensure communication of the quality objectives and priorities to all site personnel.
Manage resources according to quality objectives, site priorities & anticipate future business needs including headcount and finances.
Actively recruit, coach, and develop personnel within the Lilly quality unit.
Ensure that Quality activities are performed in accordance with procedural requirements and meet planned timelines.
Provide administrative support & technical leadership to the site quality unit.
Assure the independence of the Site Quality Unit.
Ensure the development, adequacy, and effectiveness of the site’s quality management system.
Ensure systems are in place to release or reject raw materials, intermediates, packaging materials, device components, and consumables.
Establish and ensure a system is in place for evaluating and releasing batch records in accordance with regulations and company standards.
Ensure, in partnership with the Senior Director, Quality Control, all necessary controls, testing, and monitoring are carried out with the quality control function in accordance with the marketing authorization.
Ensure, in partnership with the Senior Director, Quality Control, a system is in place for approving specification, sampling instructions, test methods & batch records.
Ensure that all required quality agreements are in place & maintained.
Ensure site processes, equipment, instruments, utilities & facilities are qualified / validated and maintained for the intended use.
Ensure that there is a process at the site to perform root cause investigation for quality matters (deviations, complaints, stability failures, results out specifications) and there is a system monitoring of corrective actions and ensure there is a process for evaluating proposed changes.
Ensure the site has a CAPA program and a quality plan where corrections and corrective actions and significant quality improvement / enhancement initiatives are described.
Ensure development, approval and implementation of Local Quality Plan and Site Quality Manual.
Ensure that a process of governance and control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, also known in IPM as CAPA board) to ensure monitoring of quality indicators applied to each element of the quality system, discuss the results and actions to improve Quality Management systems and execution (Management Review of Quality Systems).
Ensure that the notification / escalation process is effective, so there is appropriate resolution of quality problems.
Participate in approving Annual Product Reviews.
Ensure site audit & inspection readiness.
Host audits and inspections.
Assure timely closure of all regulatory commitments.
Assure the adequacy & effectiveness of the site quality systems.
Participate on the Site Lead Team and lead the Quality Lead Team.
Ensure overall compliance with GMP regulations, Lilly Corporate Quality standards and regulatory requirements through review and approval of GMP documentation.
Ensure the site has a process to maintain compliance status through gap assessment of corporate and regulatory standards and guidelines.
Ensure adequate quality oversight on GMP documents and activities (e.g., through QA presence on the shop floor).

Responsibilities

Overseeing the execution of the Quality Management System.
Ensuring compliance with cGMPs, policies, procedures and standards.
Establishing the site’s quality objectives, priorities, and roadmap.
Leading and/or participating in the assessment, development, and implementation of critical projects in support of continuous quality improvements.
Providing quality support for achieving key business objectives.
Determining and managing the work agenda and budget for the team.
Providing leadership and direction in managing product-related quality matters.
Assuring the independence of the quality unit, while making decisions regarding quality issues.
Ensuring that the products are fit for their intended use and comply with US and international regulatory requirements.
Leading and responding to regulatory agency inspections and inquiries.
Reviewing/approving GMP documentation including procedures, training, master production records, technical protocols and reports, change proposals, deviations, and corrective/preventive actions.
Responsible for the productivity, tracked through metrics, and the development/enhancement of the department’s staff using the performance management process.
Responsible for quality oversight for parenteral drug product manufacturing, device assembly, and/or packaging, as well as other Quality support functions.
Staying true to Lilly’s values of Integrity, Excellence and Respect of People.
Making sure employees are trained & understand "Red Book" ethics and compliance.
Ensuring a safe and healthy work environment.
Getting strong participation from the Q team to HSE program.
Monitoring, verifying, evaluating, and driving improvement towards site goals.
Ensuring staff is qualified, that the initial & continuous training/ GMP education of all personnel is carried out as needed.
Developing people capability & knowledge (technical expertise, behavioral & managerial).
Ensuring communication of the quality objectives and priorities to all site personnel.
Managing resources according to quality objectives, site priorities & anticipating future business needs including headcount and finances.
Actively recruiting, coaching, and developing personnel within the Lilly quality unit.
Ensuring that Quality activities are performed in accordance with procedural requirements and meet planned timelines.
Providing administrative support & technical leadership to the site quality unit.
Assuring the independence of the Site Quality Unit.
Ensuring the development, adequacy, and effectiveness of the site’s quality management system.
Ensuring systems are in place to release or reject raw materials, intermediates, packaging materials, device components, and consumables.
Establishing and ensuring a system is in place for evaluating and releasing batch records in accordance with regulations and company standards.
Ensuring, in partnership with the Senior Director, Quality Control, all necessary controls, testing, and monitoring are carried out with the quality control function in accordance with the marketing authorization.
Ensuring, in partnership with the Senior Director, Quality Control, a system is in place for approving specification, sampling instructions, test methods & batch records.
Ensuring that all required quality agreements are in place & maintained.
Ensuring site processes, equipment, instruments, utilities & facilities are qualified / validated and maintained for the intended use.
Ensuring that there is a process at the site to perform root cause investigation for quality matters (deviations, complaints, stability failures, results out specifications) and there is a system monitoring of corrective actions and ensuring there is a process for evaluating proposed changes.
Ensuring the site has a CAPA program and a quality plan where corrections and corrective actions and significant quality improvement / enhancement initiatives are described.
Ensuring development, approval and implementation of Local Quality Plan and Site Quality Manual.
Ensuring that a process of governance and control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, also known in IPM as CAPA board) to ensure monitoring of quality indicators applied to each element of the quality system, discuss the results and actions to improve Quality Management systems and execution (Management Review of Quality Systems).
Ensuring that the notification / escalation process is effective, so there is appropriate resolution of quality problems.
Participating in approving Annual Product Reviews.
Ensuring site audit & inspection readiness.
Hosting audits and inspections.
Assuring timely closure of all regulatory commitments.
Assuring the adequacy & effectiveness of the site quality systems.
Participating on the Site Lead Team and leading the Quality Lead Team.
Ensuring overall compliance with GMP regulations, Lilly Corporate Quality standards and regulatory requirements through review and approval of GMP documentation.
Ensuring the site has a process to maintain compliance status through gap assessment of corporate and regulatory standards and guidelines.
Ensuring adequate quality oversight on GMP documents and activities (e.g., through QA presence on the shop floor).

Benefits

company bonus
company-sponsored 401(k)
pension
vacation benefits
medical benefits
dental benefits
vision benefits
prescription drug benefits
flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
life insurance
death benefits
certain time off and leave of absence benefits
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)