Sr. Director, Quality Systems
AboutVoyager TherapeuticsVoyager Therapeutics (Nasdaq:
VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology.
The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging cutting-edge expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints.
Voyager's TRACER(TM) AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors.
This platform is fueling alliances with Pfizer Inc.
, Novartis Pharma AG, Neurocrine Biosciences, Inc.
, and Sangamo Therapeutics, Inc.
, as well as multiple programs in Voyager's own pipeline.
Voyager's pipeline includes wholly owned and collaborative preclinical programs in Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and other diseases of the central nervous system, with a focus on validated targets and biomarkers to enable a path to rapid potential proof-of-biology.
For more information, visit www.
voyagertherapeutics.
comJob
Summary:
The Sr.
Director, Quality Systems will provide the organization with the leadership required to develop, implement, and maintain quality systems and standards that ensures research and development activities are compliant with domestic and global regulatory guidelines and standards as well as GxP requirements.
The Sr.
Director, Quality Assurance will provide strategic and operational leadership to development of systems and procedures to support Voyager CMC, research, and development activities; including those specifically related to GxP training, inspection readiness, and internal auditing.
Position
Responsibilities:
Develop/improve Quality Systems, programs, and procedures to promote, facilitate, and ensure compliance of research and development activities with regulatory and industry standards and implement risk-based methodologies to improve efficiencies.
Collaborate heavily with other functions in the organization to create, implement, and maintain appropriate global policies and procedures to support compliance for research and development activities.
Lead development and implementation of appropriate policies and procedures related to inspections and inspection readiness.
Establish and manage the review of internal department processes for compliance with applicable GCP, GMP and/or GLP regulations or guidance.
Oversee internal inspection-readiness activities including audits.
Lead root cause analysis for investigations resulting from internal audits.
Represent findings for Quality Review Board.
Effectively communicate progress and issue resolution to appropriate internal/external stakeholders.
Represents Voyager at health authority inspections.
Establishes and ensure a robust GxP training program.
Facilitates the appropriate authoring and implementing of QA and Regulatory SOPs in addition to the review of functional SOPs.
Share best practices across relevant Voyager departments and sites to reduce duplicated efforts and ensure alignment where appropriate.
Identifies/support/implement process improvements to enhance team efficiency and effectiveness.
Facilitates resolution of problems of diverse scope using a high degree of personal judgment Ensures the Quality Systems support the strategic plan to advance the Company's mission and objectives.
Provides strategies to address compliance gaps or determines enhancements to cross-functional quality systems.
Monitors and interprets GxP regulatory guidelines and trends and incorporates into phase appropriate control strategies.
Specialized Knowledge & Skills:
Sound understanding of regulated activities, health authority expectations, and GxPs.
Experience in hosting and managing Regulatory Inspections.
Quality Assurance experience establishing and implementing GxP policies and procedures.
Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset.
Experience in representing quality to a variety of stakeholders including functional and corporate leaders.
Demonstrated Quality leadership through a partnership approach with functions to enable high quality and compliant procedures related to research and development activities.
Strong knowledge of current industry trends and the ability to use the latest technologies.
Demonstrated ability to partake or lead interdisciplinary projects, work in cross-functional matrix, and to effectuate change within a high-performing organization.
A clear sense of personal accountability, an ability to empower people, ability to drive quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.
Requirements:
Educational Requirements:
Minimum BS degree in a scientific discipline (e.
g.
, biology, chemistry, engineering, etc.
)with 10
years relevant experience.
Advanced degree (Masters/Ph.
D) with 7
years of relevant experience.
Experience:
Demonstrated quality experience with a minimum of 10 years working in a scientific /pharmaceutical/biotech industry in a quality/operational role.
Strong leadership experience including excellent communication, collaboration/consensus building, considerable organizational awareness, influencing and negotiation skills.
Experience with internal audit preparation and execution.
#J-18808-Ljbffr Recommended Skills Auditing Biology Biotechnology Business Processes Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology.
The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging cutting-edge expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints.
Voyager's TRACER(TM) AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors.
This platform is fueling alliances with Pfizer Inc.
, Novartis Pharma AG, Neurocrine Biosciences, Inc.
, and Sangamo Therapeutics, Inc.
, as well as multiple programs in Voyager's own pipeline.
Voyager's pipeline includes wholly owned and collaborative preclinical programs in Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and other diseases of the central nervous system, with a focus on validated targets and biomarkers to enable a path to rapid potential proof-of-biology.
For more information, visit www.
voyagertherapeutics.
comJob
Summary:
The Sr.
Director, Quality Systems will provide the organization with the leadership required to develop, implement, and maintain quality systems and standards that ensures research and development activities are compliant with domestic and global regulatory guidelines and standards as well as GxP requirements.
The Sr.
Director, Quality Assurance will provide strategic and operational leadership to development of systems and procedures to support Voyager CMC, research, and development activities; including those specifically related to GxP training, inspection readiness, and internal auditing.
Position
Responsibilities:
Develop/improve Quality Systems, programs, and procedures to promote, facilitate, and ensure compliance of research and development activities with regulatory and industry standards and implement risk-based methodologies to improve efficiencies.
Collaborate heavily with other functions in the organization to create, implement, and maintain appropriate global policies and procedures to support compliance for research and development activities.
Lead development and implementation of appropriate policies and procedures related to inspections and inspection readiness.
Establish and manage the review of internal department processes for compliance with applicable GCP, GMP and/or GLP regulations or guidance.
Oversee internal inspection-readiness activities including audits.
Lead root cause analysis for investigations resulting from internal audits.
Represent findings for Quality Review Board.
Effectively communicate progress and issue resolution to appropriate internal/external stakeholders.
Represents Voyager at health authority inspections.
Establishes and ensure a robust GxP training program.
Facilitates the appropriate authoring and implementing of QA and Regulatory SOPs in addition to the review of functional SOPs.
Share best practices across relevant Voyager departments and sites to reduce duplicated efforts and ensure alignment where appropriate.
Identifies/support/implement process improvements to enhance team efficiency and effectiveness.
Facilitates resolution of problems of diverse scope using a high degree of personal judgment Ensures the Quality Systems support the strategic plan to advance the Company's mission and objectives.
Provides strategies to address compliance gaps or determines enhancements to cross-functional quality systems.
Monitors and interprets GxP regulatory guidelines and trends and incorporates into phase appropriate control strategies.
Specialized Knowledge & Skills:
Sound understanding of regulated activities, health authority expectations, and GxPs.
Experience in hosting and managing Regulatory Inspections.
Quality Assurance experience establishing and implementing GxP policies and procedures.
Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset.
Experience in representing quality to a variety of stakeholders including functional and corporate leaders.
Demonstrated Quality leadership through a partnership approach with functions to enable high quality and compliant procedures related to research and development activities.
Strong knowledge of current industry trends and the ability to use the latest technologies.
Demonstrated ability to partake or lead interdisciplinary projects, work in cross-functional matrix, and to effectuate change within a high-performing organization.
A clear sense of personal accountability, an ability to empower people, ability to drive quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.
Requirements:
Educational Requirements:
Minimum BS degree in a scientific discipline (e.
g.
, biology, chemistry, engineering, etc.
)with 10
years relevant experience.
Advanced degree (Masters/Ph.
D) with 7
years of relevant experience.
Experience:
Demonstrated quality experience with a minimum of 10 years working in a scientific /pharmaceutical/biotech industry in a quality/operational role.
Strong leadership experience including excellent communication, collaboration/consensus building, considerable organizational awareness, influencing and negotiation skills.
Experience with internal audit preparation and execution.
#J-18808-Ljbffr Recommended Skills Auditing Biology Biotechnology Business Processes Coaching And Mentoring Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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