BioSpace
Senior Director, Global Process Owner - Quality Risk Management
BioSpace, Indianapolis, Indiana, us, 46262
Overview
Senior Director, Global Process Owner - Quality Risk Management 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. Responsibilities
Establish and maintain the global quality system for Quality Risk Management (QRM) to drive standardization globally. Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitate accurate reporting and analytics. Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. Actively collaborate with enterprise-wide teams on standardized global business processes. As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. Actively engage in external organizations and industry organizations to monitor policy changes for regulatory/external environments and advocate/influence quality related policies and regulatory requirements related to Quality Risk Management. Own the global risk log and global risk register, ensuring key quality risks across the enterprise are actively mitigated. Support the Quality Maturity Model initiatives by actively enhancing the cultural mindset across the enterprise to integrate QRM principles into routine processes. Basic Requirements
10+ years’ experience in the pharmaceutical industry in GxP roles, with several years Quality experience. Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. Additional Skills/Preferences
Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control. Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. Proficiency in addressing operational challenges through structured approaches and innovative solutions. Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. Demonstrated change agility in anticipating and leading others through change and ambiguity. Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. Demonstrated people management experience. Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. Prior experience with common QRM tools, how and when to apply them, and maintenance of a risk log or risk register. Prior experience working in at least two of Clinical Operations/Development, Pharmacovigilance, Product Research & Development or Commercial Manufacturing (preferred). Additional Information
Available to travel (domestic and international) when required. Fluent in English; additional languages are recommended. Role may be based at selected Lilly locations in Europe or the US. 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. 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 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200. Full-time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefits program including medical/dental/vision, life insurance, 401(k), pension, vacation, flexible spending accounts, and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #WeAreLilly
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Senior Director, Global Process Owner - Quality Risk Management 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. Responsibilities
Establish and maintain the global quality system for Quality Risk Management (QRM) to drive standardization globally. Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitate accurate reporting and analytics. Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. Actively collaborate with enterprise-wide teams on standardized global business processes. As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. Actively engage in external organizations and industry organizations to monitor policy changes for regulatory/external environments and advocate/influence quality related policies and regulatory requirements related to Quality Risk Management. Own the global risk log and global risk register, ensuring key quality risks across the enterprise are actively mitigated. Support the Quality Maturity Model initiatives by actively enhancing the cultural mindset across the enterprise to integrate QRM principles into routine processes. Basic Requirements
10+ years’ experience in the pharmaceutical industry in GxP roles, with several years Quality experience. Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. Additional Skills/Preferences
Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control. Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. Proficiency in addressing operational challenges through structured approaches and innovative solutions. Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. Demonstrated change agility in anticipating and leading others through change and ambiguity. Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. Demonstrated people management experience. Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. Prior experience with common QRM tools, how and when to apply them, and maintenance of a risk log or risk register. Prior experience working in at least two of Clinical Operations/Development, Pharmacovigilance, Product Research & Development or Commercial Manufacturing (preferred). Additional Information
Available to travel (domestic and international) when required. Fluent in English; additional languages are recommended. Role may be based at selected Lilly locations in Europe or the US. 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. 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 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200. Full-time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefits program including medical/dental/vision, life insurance, 401(k), pension, vacation, flexible spending accounts, and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #WeAreLilly
#J-18808-Ljbffr