Aldevron
Sr. Manager Operational QA
Aldevron, Fargo, North Dakota, us, 58126
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or you are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality Assurance located in Fargo, ND and will be on-site. You will be a part of the Operational Quality Assurance team and report to the Sr. Director, QA, responsible for developing and implementing quality assurance strategies to support the production, final packaging, and labeling of drug product.
In this role, you will have the opportunity to:
Collaborate with cross-functional teams to establish quality assurance strategies aligned with regulatory requirements and industry best practices. This includes defining quality standards, implementing quality assurance processes, and continuously improving quality systems required to produce safe and effective drug products.
Provide daily leadership and management for the teams that report into this position to drive excellence in quality-related functions, including coaching, developing, and performance managing when needed. Teams include Operational Quality Assurance, Incoming Quality Assurance, and Labeling.
Ensure materials used in operations and the resulting drug products produced from these materials comply with all applicable regulatory requirements. Stay up to date with applicable regulations, guidelines, and standards from regulatory bodies such as the FDA, EMA, and other relevant authorities. Develop and maintain quality systems and processes that comply with these standards, including GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices).
Manage quality metrics and reporting: Develop key performance indicators (KPIs) and metrics to monitor quality performance across Incoming and Operational Quality Assurance (IQA and OQA). Prepare and deliver regular reports to Daily Management and Bowler reports, identifying and highlighting trends, areas of improvement, recommended actions, and timely execution of those actions.
Collaborate with stakeholders: Work closely with manufacturing, supply chain, regulatory affairs, Quality Control, and other relevant departments to ensure alignment on quality objectives, resolve quality-related issues, and drive improvements across the entire product lifecycle in a compliant manner.
Provide training and guidance: Develop and deliver training programs to enhance quality awareness and compliance. Provide guidance and support to cross-functional teams on quality-related matters, including SOP (Standard Operating Procedure) development and adherence.
The essential requirements of the job include:
7+ years of relevant experience in drug product operational quality position required, minimum of 2 years in a managerial position.
7+ years of experience with final drug product manufacturing with incoming and in-process acceptance activities.
Bachelor’s degree required; life science related field preferred.
Track record of compliance in the application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Labeling experience in an FDA regulated environment preferred.
Strong foundational knowledge in FDA and EU regulations in manufacturing biologics such as: 21 CFR Part 210, 211, 610, EudraLex Vol 4, ICH Q7, ICH Q8, ICH Q9, ICH Q10.
#J-18808-Ljbffr
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality Assurance located in Fargo, ND and will be on-site. You will be a part of the Operational Quality Assurance team and report to the Sr. Director, QA, responsible for developing and implementing quality assurance strategies to support the production, final packaging, and labeling of drug product.
In this role, you will have the opportunity to:
Collaborate with cross-functional teams to establish quality assurance strategies aligned with regulatory requirements and industry best practices. This includes defining quality standards, implementing quality assurance processes, and continuously improving quality systems required to produce safe and effective drug products.
Provide daily leadership and management for the teams that report into this position to drive excellence in quality-related functions, including coaching, developing, and performance managing when needed. Teams include Operational Quality Assurance, Incoming Quality Assurance, and Labeling.
Ensure materials used in operations and the resulting drug products produced from these materials comply with all applicable regulatory requirements. Stay up to date with applicable regulations, guidelines, and standards from regulatory bodies such as the FDA, EMA, and other relevant authorities. Develop and maintain quality systems and processes that comply with these standards, including GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices).
Manage quality metrics and reporting: Develop key performance indicators (KPIs) and metrics to monitor quality performance across Incoming and Operational Quality Assurance (IQA and OQA). Prepare and deliver regular reports to Daily Management and Bowler reports, identifying and highlighting trends, areas of improvement, recommended actions, and timely execution of those actions.
Collaborate with stakeholders: Work closely with manufacturing, supply chain, regulatory affairs, Quality Control, and other relevant departments to ensure alignment on quality objectives, resolve quality-related issues, and drive improvements across the entire product lifecycle in a compliant manner.
Provide training and guidance: Develop and deliver training programs to enhance quality awareness and compliance. Provide guidance and support to cross-functional teams on quality-related matters, including SOP (Standard Operating Procedure) development and adherence.
The essential requirements of the job include:
7+ years of relevant experience in drug product operational quality position required, minimum of 2 years in a managerial position.
7+ years of experience with final drug product manufacturing with incoming and in-process acceptance activities.
Bachelor’s degree required; life science related field preferred.
Track record of compliance in the application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Labeling experience in an FDA regulated environment preferred.
Strong foundational knowledge in FDA and EU regulations in manufacturing biologics such as: 21 CFR Part 210, 211, 610, EudraLex Vol 4, ICH Q7, ICH Q8, ICH Q9, ICH Q10.
#J-18808-Ljbffr