Sr Director/Director, Quality Operations
clinovo
COMPANY IN SEATTLE -ONSITE
Position Overview
The Senior Director/Director of Quality Operations is a key leader responsible for upholding the highest standards of quality and compliance across all operational areas. This role works closely with both internal and external stakeholders to ensure product quality and regulatory adherence throughout the entire product lifecycle, from development to commercialization.
In this position, the Director/Senior Director develops and leads quality programs for commercial and clinical manufacturing operations, ensuring alignment with global regulatory requirements. The role regularly engages with executive leadership to communicate quality initiatives, address issues, and outline resource needs. Additionally, the position oversees quality assurance (QA) activities across various functional areas and manufacturing sites, leads internal and external audits, and drives continuous improvement in quality systems.
Responsibilities
Quality Operations Oversee drug substance, drug product, packaging, labeling, serialization, and third-party logistics operations, ensuring seamless coordination across all stages of the supply chain. Review and approve product quality specifications, manage the development of master batch records, and oversee process/method validation reports and other technical documents supporting the full product lifecycle from development through commercialization. Manage batch disposition for early-phase and commercial products, ensuring compliance with quality standards. Ensure adherence to GMP-related processes, including CAPA management, change controls, deviations, and other quality management activities during manufacturing and testing. Collaborate with manufacturing, clinical, and other functional teams to support quality operations and resolve issues impacting product quality. Conduct risk assessments and implement robust quality and process controls to ensure effective oversight of production activities. Support vendor qualification programs, monitor vendor performance, and ensure vendors meet quality expectations. Documentation and Record Control Conduct periodic reviews, revisions, and approvals of SOPs, policies, and Quality Agreements to ensure alignment with regulatory updates, business needs, and proper management. Regulatory Compliance and Inspection Readiness Ensure external parties are inspection-ready and compliant with GMP audits or inspections from FDA and international regulatory bodies, while supporting site preparation, personnel training, and readiness. Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, providing necessary documentation and ensuring compliance with filing requirements. Operational Leadership and Continuous Improvement Lead continuous improvement initiatives within quality operations to boost operational efficiency, minimize risk, and enhance product quality. Offer strategic guidance and hands-on leadership to operations teams, ensuring alignment with business objectives and regulatory requirements. Team Leadership and Development
Qualifications Mentor and coach a high-performing quality team to foster organizational growth. Establish performance objectives for team members and oversee their development through regular performance assessments.
Education and Experience Bachelor's degree in life sciences, chemistry, engineering, or a related field; an advanced degree (MS, PhD, MBA) is preferred. At least 15 years of experience in quality assurance, quality systems, and/or quality operations within the pharmaceutical, biotechnology, or life sciences sectors, including a minimum of 5 years in a leadership role. Skills And Competencies Extensive experience in overseeing GMP operations and Quality Management Systems (QMS), including vendor oversight and contract manufacturing organization (CMO) management. In-depth knowledge of FDA, EMA, ICH, and other international regulatory standards and their implementation in Quality Operations. Background in supporting both clinical and commercial programs. Strong strategic thinker with excellent project management, organizational, and leadership abilities, adept at multitasking and prioritizing in dynamic environments. Proven capability to lead cross-functional teams and effectively manage external vendors and stakeholders. Experienced in the manufacturing processes of both biologics and small molecules.
Travel Position may require domestic and international travel (up to 25%). Clinovo’s mission is to empower healthcare and life science companies by providing expertise in sourcing and placing top clinical research professionals across a multitude of diverse opportunities. We have a proven track record with pharmaceutical, biotechnology, diagnostic, medical device, and CRO customers. Leading companies have chosen Clinovo as their preferred partner for its quality of customer service, excellent candidate profile, and it’s long-term.
Base salary compensation MID range: $197.5-$226K-
Please note, the base salary offered to the final candidate depends on relevant work experience, skills, and years of experience, along with Director or Sr. Director title
Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
Position Overview
The Senior Director/Director of Quality Operations is a key leader responsible for upholding the highest standards of quality and compliance across all operational areas. This role works closely with both internal and external stakeholders to ensure product quality and regulatory adherence throughout the entire product lifecycle, from development to commercialization.
In this position, the Director/Senior Director develops and leads quality programs for commercial and clinical manufacturing operations, ensuring alignment with global regulatory requirements. The role regularly engages with executive leadership to communicate quality initiatives, address issues, and outline resource needs. Additionally, the position oversees quality assurance (QA) activities across various functional areas and manufacturing sites, leads internal and external audits, and drives continuous improvement in quality systems.
Responsibilities
Quality Operations Oversee drug substance, drug product, packaging, labeling, serialization, and third-party logistics operations, ensuring seamless coordination across all stages of the supply chain. Review and approve product quality specifications, manage the development of master batch records, and oversee process/method validation reports and other technical documents supporting the full product lifecycle from development through commercialization. Manage batch disposition for early-phase and commercial products, ensuring compliance with quality standards. Ensure adherence to GMP-related processes, including CAPA management, change controls, deviations, and other quality management activities during manufacturing and testing. Collaborate with manufacturing, clinical, and other functional teams to support quality operations and resolve issues impacting product quality. Conduct risk assessments and implement robust quality and process controls to ensure effective oversight of production activities. Support vendor qualification programs, monitor vendor performance, and ensure vendors meet quality expectations. Documentation and Record Control Conduct periodic reviews, revisions, and approvals of SOPs, policies, and Quality Agreements to ensure alignment with regulatory updates, business needs, and proper management. Regulatory Compliance and Inspection Readiness Ensure external parties are inspection-ready and compliant with GMP audits or inspections from FDA and international regulatory bodies, while supporting site preparation, personnel training, and readiness. Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, providing necessary documentation and ensuring compliance with filing requirements. Operational Leadership and Continuous Improvement Lead continuous improvement initiatives within quality operations to boost operational efficiency, minimize risk, and enhance product quality. Offer strategic guidance and hands-on leadership to operations teams, ensuring alignment with business objectives and regulatory requirements. Team Leadership and Development
Qualifications Mentor and coach a high-performing quality team to foster organizational growth. Establish performance objectives for team members and oversee their development through regular performance assessments.
Education and Experience Bachelor's degree in life sciences, chemistry, engineering, or a related field; an advanced degree (MS, PhD, MBA) is preferred. At least 15 years of experience in quality assurance, quality systems, and/or quality operations within the pharmaceutical, biotechnology, or life sciences sectors, including a minimum of 5 years in a leadership role. Skills And Competencies Extensive experience in overseeing GMP operations and Quality Management Systems (QMS), including vendor oversight and contract manufacturing organization (CMO) management. In-depth knowledge of FDA, EMA, ICH, and other international regulatory standards and their implementation in Quality Operations. Background in supporting both clinical and commercial programs. Strong strategic thinker with excellent project management, organizational, and leadership abilities, adept at multitasking and prioritizing in dynamic environments. Proven capability to lead cross-functional teams and effectively manage external vendors and stakeholders. Experienced in the manufacturing processes of both biologics and small molecules.
Travel Position may require domestic and international travel (up to 25%). Clinovo’s mission is to empower healthcare and life science companies by providing expertise in sourcing and placing top clinical research professionals across a multitude of diverse opportunities. We have a proven track record with pharmaceutical, biotechnology, diagnostic, medical device, and CRO customers. Leading companies have chosen Clinovo as their preferred partner for its quality of customer service, excellent candidate profile, and it’s long-term.
Base salary compensation MID range: $197.5-$226K-
Please note, the base salary offered to the final candidate depends on relevant work experience, skills, and years of experience, along with Director or Sr. Director title
Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
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