Associate Director - GQAAC GMP Pharmaceutical

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Brand Description:

The Assoc. Director – GQAAC GMP Pharmaceutical role is part of the Global Quality Auditing and Compliance (GQAAC) division and represents the Global Quality Auditing interface for the commercial manufacturing organization. The position assures that an effective audit program is maintained that monitors global Lilly operations and Contract Manufacturers. It ensures that operations are performed in accordance with company standards, policies, practices and procedures and are compliant with current regulations and guidelines. This position involves supervision of an auditing staff that audits Lilly operations, both internally and externally (contracted), in support of the GQA Audit Strategy and in performance of Quality Due Diligence.

GQAAC is a valued business partner and takes a proactive approach to further enhancing the quality of business operations and regulatory compliance. The Assoc. Director – GQAAC GMP Pharmaceutical plays a key part in contributing to the implementation of this strategic approach to quality auditing and oversight within Lilly.

Key Objectives/Deliverables:

1. Team Management

• Provide leadership and supervision to auditing team
• Ensure that staff receives appropriate training and is aligned at appropriate staffing level
• Ensure development of employee skills and knowledge to allow proficient execution of responsibilities.
• Work with management team to set departmental strategy and objectives.
• Ensure all direct reporting employees have a performance management and development plan in place and carry out their objectives and responsibilities.

2. Business/Strategic Leadership/Auditing

• Work with management team to develop audit plan for auditable units within area of responsibility that aligns with the overall departmental audit plan for the corporation
• Ensure audit processes are robust and ensure qualified personnel are assigned to product/project support and audit teams; direct resources in the execution of audit plan
• Ensure consistency between audits
• Review and approve audit and assessment reports and summaries in alignment with expectations
• Perform site audits
• Develop with management team, communications on audit findings to senior management
• Escalate any significant compliance issues to relevant site, development and quality management

3. Standards

• Review and provide input to departmental corporate standards, policies and procedures
• Ensure consistency of content of standards with requirements

4. Personal Development and Shared Learning

• Attend training courses, conferences or association meetings to continue to gain knowledge; share such information with other members of the team or company to increase awareness and to train others in the implementation of these practices
• Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements
• Continue to gain knowledge necessary to provide a greater understanding of GMP requirements

5. Divisional/Global Quality Organization Support

• Participate in projects as directed by Sr. Director, Global Quality Auditing & Compliance that support or enhance GMP compliance of larger quality organization’s ability to carry out mission and meet objectives
• Participate in global projects/work groups as representative of GQAAC

Minimum Requirements:

• Minimum Bachelor’s Degree in Pharmacy, Chemistry, Biology, Engineering, Microbiology, or other technical areas of study
• Minimum of 10 years relevant industry experience in areas that must include: quality assurance or quality control

Additional Preferences:

• Experience in development operations, manufacturing operations or technical services in addition to quality is preferred
• Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent oral and written communication and oral presentation skills
• Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills
• Ability to work independently and as part of a team with minimal supervision
• Travel
• Previous auditing experience

Other Information:

• Must be able to work in a manufacturing environment
• Individual must not be sensitive to penicillin/cephalosporin
• Must be able to travel 25-35% including international travel

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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