Plant Quality Leader
- Indianapolis, IN
- Permanent
- Full-time
- Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent, and grow team capabilities
- Develop individuals and team to ensure continuous professional development
- Sponsor, develop, and support the site Safety, Quality, and Compliance initiatives and culture.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- Support the plant business plan and influence plant agenda to ensure reliable supply of quality medicine, strong quality culture, and maintenance of cGMP compliance and inspection readiness
- Participate actively on the plant lead team, Site Quality Lead Team, functional lead teams, and other governance instances at the plant / site (as appropriate)
- Serve as a conduit for site, network, and corporate communications
- Communicate to and strive for integration of support groups outside plant
- Benchmark and network with other Lilly sites and PR&D for communications and shared learning (best practices, learnings, etc.)
- 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 forum (e.g., Site Lead Team)
- Create and manage Site Quality Plan; maintain technical and compliance consistency across plants
- Ensure Plant inspection readiness
- Participate and, when needed, coordinate and manage regulatory inspections
- Provide guidance to significant investigations and compliance gaps at site level
- Approve (or reject) technical and quality documents that, per local procedures, require quality director level approval such as major deviations, major changes, L3 complaints, etc. and / or other documents within their areas of responsibility that, per Lilly Quality Standards, might require Site Quality Leader level approval when described in local procedures (this includes approval of Level 3 complaints, major deviations and changes, approval of date extension requests and due date changes, approval of process validation protocols and reports, approval of validation master plans, approval of risk-based rationale if bracketing of products is used for cleaning validation, etc.)
- Ensure adequate quality oversight for manufacturing operations within their plant and areas of responsibility
- Act as primary back-up for other Quality Assurance Directors and, upon delegation of authority, the Site Quality Leader.
- BSc or MSc in scientific or technical degree: chemistry, biology, microbiology, pharmacy, engineering, or equivalent scientific / technical degree.
- 8+ years of experience in pharmaceutical industry with demonstrated successful leadership experience.
- Good knowledge of cGMP, external Regulations, and Lilly Quality Systems requirements.
- Experience in Production, Quality Control, Quality Assurance, Technical Services, and / or Regulatory, or Administration is desirable.
- Strong influencing skills and interpersonal and teamwork skills.
- Excellent communication 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
- Overtime may be required.
- May be required to respond to calls off shift to resolve operational issues.
- Applicant will work in 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.