Associate Director Quality Assurance for Operations

Associate Director Quality Assurance for Operations

01 Jun 2022
Indiana, Indianapolis, 46201 Indianapolis USA

Associate Director Quality Assurance for Operations

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 35,000 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.Organization OverviewAt Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerismThe Quality Assurance Operations Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.The Associate Director for QA Operations is responsible for providing leadership and daily support and oversight to GMP operations at Indianapolis Manufacturing. The Associate Director is responsible for managing the activities of Quality Assurance personnel supporting Indy Parenteral Operations, with respect to regulatory requirements, procedural interpretation and training, regulatory agency inspections and maintenance of inspection readiness within those areas.Responsibilities:Team and personnel development: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

Develop, lead, and support the site Safety, Quality and Compliance initiatives and culture.

Scope of team may comprise of primary loop (process team), secondary loop, on-shift support (exempt and non-exempt), and/or batch review quality reps.

Plant leadership: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.)

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 forum (e.g Plant Lead Team)

Support Site Quality Plan; maintain technical and compliance consistency across plants

Ensure Plant inspection readiness

Participate and when needed to support regulatory inspections

Provide guidance to significant investigations and compliance gaps at plant/flow level

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 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 Plant Quality Leader.

Basic Requirements:BSc or MSc in scientific or technical degree: chemistry, biology, microbiology, pharmacy, engineering

3 years of experience

Additional Skills/Preferences: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

Demonstrated relevant experience in a regulated manufacturing environment

Proficiency with computer systems including Microsoft Office products

Demonstrate strong oral and written communication and interpersonal skills

Experience with being a mentor, coach and/or giving and receiving feedback

Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements

Experience in Production, QC, QA, Technical Services, Engineering or Regulatory is desirable.

Experience in pharmaceutical industry

Demonstrated successful leadership experience

Previous experience with Lilly non-conformance and change control process

Additional Information:Overtime may be required.

May be required to respond to calls offshift 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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