BioSpace
Overview
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Plant Quality Leader
role at
BioSpace .
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 Plant Quality Leader
in Indianapolis Parenteral Manufacturing serves as the leader for the quality assurance organization in one of the plants. They are responsible to lead and develop the QA team. They serve as a Site / Plant agent to manage compliance to all cGMP procedures, policies, and guidelines; support issue resolution, and approve recommendations related to product quality. They work cross-functionally to lead the plant by supporting completion of key initiatives and meeting the business plan as well as enabling and sustaining the site / plant safety, quality, and compliance culture.
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. Sponsor, develop, and support the site Safety, Quality, and Compliance initiatives and culture.
Plant Leadership: Maintain a safe work environment, work safely, and support 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. Actively participate on the plant lead team, Site Quality Lead Team, functional lead teams, and other governance instances at the plant/site. 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.
Plant Quality And Compliance Oversight: Exhibit critical business decision making taking into consideration quality, compliance, and business aspects; escalate critical quality issues when appropriate and propose decisions. 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 require quality director level approval as described in local procedures. Ensure adequate quality oversight for manufacturing operations within the plant and areas of responsibility. Act as primary back-up for other Quality Assurance Directors and, upon delegation of authority, the Site Quality Leader.
Basic Requirements
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.
Additional Skills / Preferences
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.
Other Information
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.
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 for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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Plant Quality Leader
role at
BioSpace .
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 Plant Quality Leader
in Indianapolis Parenteral Manufacturing serves as the leader for the quality assurance organization in one of the plants. They are responsible to lead and develop the QA team. They serve as a Site / Plant agent to manage compliance to all cGMP procedures, policies, and guidelines; support issue resolution, and approve recommendations related to product quality. They work cross-functionally to lead the plant by supporting completion of key initiatives and meeting the business plan as well as enabling and sustaining the site / plant safety, quality, and compliance culture.
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. Sponsor, develop, and support the site Safety, Quality, and Compliance initiatives and culture.
Plant Leadership: Maintain a safe work environment, work safely, and support 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. Actively participate on the plant lead team, Site Quality Lead Team, functional lead teams, and other governance instances at the plant/site. 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.
Plant Quality And Compliance Oversight: Exhibit critical business decision making taking into consideration quality, compliance, and business aspects; escalate critical quality issues when appropriate and propose decisions. 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 require quality director level approval as described in local procedures. Ensure adequate quality oversight for manufacturing operations within the plant and areas of responsibility. Act as primary back-up for other Quality Assurance Directors and, upon delegation of authority, the Site Quality Leader.
Basic Requirements
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.
Additional Skills / Preferences
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.
Other Information
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.
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 for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
#J-18808-Ljbffr