Associate Director - Site Quality & Compliance (Complaints and GMP Library Oversight)

Description

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 Site Quality & Compliance Organization assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Manufacturing's central quality processes.

The Associate Director for Site Quality & Compliance is responsible for managing the activities of Quality personnel supporting central quality processes which may include a combination of quality oversight for laboratories, stability, materials, data stewardship, complaints, regulatory interactions, inspection readiness, and quality system ownership.

Position Focus: This position will be responsible for complaint investigation management and oversight of the IPM GMP Library within the Site Quality & Compliance team. Cross-training to back-up other Site Quality and Compliance Associate Directors is expected.

Key Objectives / Deliverables:

Team and Personnel Development:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely, and accountable for supporting all HSE Corporate and Site Goals
• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent and grow team capabilities.
• Provide Feedback and Coaching to employees
• Develop individuals and team to ensure continuous professional development
• Develop, lead, and support the site Safety, Quality, and Compliance initiatives and culture
• Scope of team may comprise of exempt and non-exempt employees.

Leadership:

• Support the site business plan and influence agenda to ensure reliable supply of quality medicine, strong quality culture and maintenance of cGMP compliance and inspection readiness
• Actively participate governance instances across the site based on assigned areas of focus
• Serve as a conduit for site, network, and corporate communications
• Interact and engage with other areas in the site
• Benchmark and network with other Lilly sites and Global Quality for communications and shared learning (best practices, learnings, etc.).

Quality and Compliance Oversight:

• Exhibit critical business decision making taking into consideration quality, compliance, and business aspects, escalate critical quality issues, when appropriate, on a timely manner and proposing decisions into the escalation forums
• Support Site Quality Plan and lead continuous improvement compliance initiatives
• Ensure inspection readiness across the site focusing on areas of responsibility
• Participate and lead others in support of regulatory inspections
• Provide guidance to significant investigations and compliance gaps across the site
• Approve (or reject) technical and quality documents that per local procedures requiring quality M2 level approval such as moderate deviations, changes, complaints, etc.
• Ensure adequate quality oversight within their areas of responsibility
• Act as primary back-up for other Associate Directors in Site Quality and Compliance, upon delegation of authority, the Sr. Director - Site Quality & Compliance.

Basic Requirements:

• BSc or MSc in scientific or technical degree: chemistry, biology, microbiology, pharmacy, engineering.
• Minimum 5-7 years demonstrated relevant experience in a regulated manufacturing environment; demonstrated leadership experience within pharmaceutical industry preferred.

Additional Preferences:

• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements
• Experience in Production, QC, QA, Technical Services, Engineering, or Regulatory is desirable.
• Previous experience executing with Lilly Quality Systems (deviations, analytical investigations, change, and / or complaints).
• Strong influencing, interpersonal, and teamwork skills.
• Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment
• Proficiency with computer systems including Microsoft Office products
• Demonstrate strong oral and written communication.
• Experience with being a mentor, coach and / or giving and receiving feedback.

Other Information:

• Overtime may be required
• May be required to respond to site compliance and business needs outside of core business hours and days
• Applicant will be exposed to various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position
• Some OUS and US travel may be required.

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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly