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.
Main Purpose and Objectives: The Associate Director-Quality Assurance is responsible for leading, educating, facilitating, enforcing, and ensuring compliance with Good Manufacturing Practices (GMP) and Corporate Quality policies. This role serves as a liaison between flow teams and the Quality Management Department. The Associate Director is responsible for legacy process and/or commercialization support, quality systems owner and oversight, Capital Projects, inspection management and acts as the responsible person for all current GMP matters in the absence of the Sr. Director-Quality.
Job responsibilities:
- Ensure compliance with GMPs and quality corporate policies.
- Drive compliance decisions for the site initiatives and processes.
- Assure inspection readiness for internal and external audits.
- Interact with auditors internal and external during GMP inspections.
- Actively seek to expand knowledge of technology and applicable regulations through external trainings and reading.
- Participate in strategic planning and measurable to the business.
- Implement operational systems that support the business strategies assuring compliance with applicable regulations.
- Responsible for the timely completion of deviations, changes, batch disposition activities managed by direct reports.
- Provide oversight and guidance for the compliance aspects of the operation.
- Design, approve, and communicate departmental objectives and applicable metrics.
- Lead quality assurance professionals and ensure the development of personnel in accordance with job requirements.
- Participate in the preparation of the departmental budget and capital planning.
- Lead and coach quality assurance front line including process, laboratory and compliance.
Requirements:
- Knowledgeable on requirements of regulatory agencies (BLA and NDA).
- Experience in audit management and interactions with Regulatory entities such as FDA, EMEA, OSHA, EPA, DEA, etc.
- Knowledgeable of all quality systems such as deviation, changes, batch disposition, laboratory practices, and material management.
- Experience in commercialization of new molecules, with knowledge on compliance/ regulatory aspects associated to new molecule introduction (prefer).
- Experience with asset delivery, process and computer system validation, facilities and equipment qualification and computer system.
- Experience as supervisor in a GMP facility.
Basic Requirements:
- BS in Chemistry, Biology, Microbiology, Pharmacy or Chemical Engineering.
- 10+ years of experience in Quality Assurance in a highly regulated pharma manufacturing environment.
- At least 5 years of supervisory experience.
Other Requirements:
- Fully bilingual (English and Spanish) with excellent written and verbal communication skills.
- Establish positive interpersonal relations and interact effectively with people.
- Work under time pressure and be flexible and agile when priorities change.
- Anticipate implications and consequences of situations and take appropriate action.
- Use a logical, systematic approach to problem-solving.
- Identify information needed to clarify a situation and seek that information from appropriate sources.
- Focus on desired end results, set challenging objectives, and meet or exceed those objectives.
- Influence and teach others.
- Strong compliance mindset and sound judgement.
- Lead and organize work priorities and objectives, aligned with the business vision and mission.
- Act as a leader, integrator, and have accountability for objectives, ensuring safety, quality, and compliance.
- Lead a diverse team and manage performance and development.
- Ensure there is an adequate number of qualified personnel to support the operation.
- Manage the budget and provide input to the Strategic and Business Planning processes.
Knowledge:
- Technical expertise in pharmaceutical operations and related sciences.
- Managing multiple project objectives.
- Technical writing and current GMPs.
- Computer (PC) literate.
Availability:
- Travel within and outside Puerto Rico and the United States.
- Work as a resource in other strategic areas of the business based on business needs.
- Provide support during irregular hours, shifts rotation, weekends, and holidays if required.