BioSpace
Associate Director, Quality Assurance – Site Data Leader
BioSpace, Pleasant Prairie, Wisconsin, United States, 53158
Overview
Associate Director, Quality Assurance – Site Data Leader
at BioSpace. The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. This role serves as an advocate for data management across the manufacturing site and chairs the site data lead team. It also provides computer system quality assurance oversight during the start-up and routine operation of the Lilly Kenosha County site, with a transition to a site-based data management and analytics leader role for routine production. 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 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 are seeking individuals determined to make life better for people around the world. Responsibilities
Develop and maintain a comprehensive and integrated data integrity and data management program for the site. Facilitate the Site Data Lead Team and partner with global and site leadership to prioritize data integrity initiatives and allocate cross-functional resources. Collaborate with functional site data SMEs to ensure data management actions are completed per plan. Maintain Data Flow Maps to identify data integrity risks and define mitigation strategies. Support data integrity improvements across documents, systems, and processes (e.g., audit trails, user access, walk-throughs, Site Self Inspection). Implement data standards and usage guidelines to manage data across its lifecycle and enable robust decision making. Lead data strategy actions (digitization, contextualization, visualization) to enable data-driven decisions, productivity, and continuous improvement. Own site actions related to enterprise data management and integrity initiatives. Maintain site data management metrics and report status to the Site Data Lead Team; operationalize the data management action plan, including transition from paper to digitized solutions. Enhance and sustain data integrity principles throughout the data lifecycle; ensure compliance and inspection readiness at the site level. Oversee data integrity training programs to sustain continuous improvement. Qualifications
Bachelor's degree required; engineering or computer science-related field preferred. Minimum 5 years in the pharmaceutical or medical device industry in QA roles. Minimum 3 years in Computer System Quality Assurance/Computer System Validation. Minimum 3 years of experience with data analytics including advanced analytics. Additional Skills/Preferences
Leadership of cross-functional teams and project management experience. Proficiency with GMP computer systems validation and related regulations. Knowledge of data integrity regulatory guidance and application of analytics for manufacturing. Strong oral and written communication, self-management, organizational and interpersonal skills. Experience with facility start-ups, qualification/validation, Six Sigma Green Belt or Lean training, and ASQ CQA certification preferred. Additional Information
Position requires onsite presence with flexible time; ability to travel up to 10%. The job description is a general overview and may evolve. Lilly is an equal opportunity employer and provides accommodations for applicants with disabilities upon request. Lilly does not discriminate on any legally protected status.
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Associate Director, Quality Assurance – Site Data Leader
at BioSpace. The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. This role serves as an advocate for data management across the manufacturing site and chairs the site data lead team. It also provides computer system quality assurance oversight during the start-up and routine operation of the Lilly Kenosha County site, with a transition to a site-based data management and analytics leader role for routine production. 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 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 are seeking individuals determined to make life better for people around the world. Responsibilities
Develop and maintain a comprehensive and integrated data integrity and data management program for the site. Facilitate the Site Data Lead Team and partner with global and site leadership to prioritize data integrity initiatives and allocate cross-functional resources. Collaborate with functional site data SMEs to ensure data management actions are completed per plan. Maintain Data Flow Maps to identify data integrity risks and define mitigation strategies. Support data integrity improvements across documents, systems, and processes (e.g., audit trails, user access, walk-throughs, Site Self Inspection). Implement data standards and usage guidelines to manage data across its lifecycle and enable robust decision making. Lead data strategy actions (digitization, contextualization, visualization) to enable data-driven decisions, productivity, and continuous improvement. Own site actions related to enterprise data management and integrity initiatives. Maintain site data management metrics and report status to the Site Data Lead Team; operationalize the data management action plan, including transition from paper to digitized solutions. Enhance and sustain data integrity principles throughout the data lifecycle; ensure compliance and inspection readiness at the site level. Oversee data integrity training programs to sustain continuous improvement. Qualifications
Bachelor's degree required; engineering or computer science-related field preferred. Minimum 5 years in the pharmaceutical or medical device industry in QA roles. Minimum 3 years in Computer System Quality Assurance/Computer System Validation. Minimum 3 years of experience with data analytics including advanced analytics. Additional Skills/Preferences
Leadership of cross-functional teams and project management experience. Proficiency with GMP computer systems validation and related regulations. Knowledge of data integrity regulatory guidance and application of analytics for manufacturing. Strong oral and written communication, self-management, organizational and interpersonal skills. Experience with facility start-ups, qualification/validation, Six Sigma Green Belt or Lean training, and ASQ CQA certification preferred. Additional Information
Position requires onsite presence with flexible time; ability to travel up to 10%. The job description is a general overview and may evolve. Lilly is an equal opportunity employer and provides accommodations for applicants with disabilities upon request. Lilly does not discriminate on any legally protected status.
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