Cytokinetics
Associate Director, GVP Quality Assurance
Cytokinetics, South San Francisco, California, us, 94083
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
As the Associate Director, Good Pharmacovigilance Practice (GVP) Quality Assurance, you are a key member of the Clinical Quality team representing Clinical QA in cross functional setting, and advising Cytokinetics Drug Safety and Pharmacovigilance teams on GVP matters. This role will liaise and interface with internal and external stakeholders to assess and support GVP compliance with local, GVP guidelines and applicable regulations to drive and maintain quality standards and regulatory compliance culture at Cytokinetics. The ideal candidate has a quality mindset in global clinical development and oversees quality activities including but not limited to representing QA on clinical study teams, inspection readiness, internal and external audits with a proven ability to manage multiple complex projects. You will lead, execute and manage GVP QA activities while being an advocate to driving quality and regulatory compliance culture at Cytokinetics.
This is an excellent opportunity to help enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of Cytokinetics growth!
Responsibilities
Responsibilities include QA Lead to ensure Good Pharmacovigilance Practice (GVP) compliance and the quality of all deliverables including:
Develop, implement, and maintain the Pharmacovigilance Quality Management System (PV QMS) ensuring alignment with global regulatory requirements (ICH, FDA, EMA, etc.)
Establish and oversee quality standards, processes, and procedures for all safety surveillance activities related to investigational drugs
Ensure the PV QMS supports corporate compliance with domestic and international adverse event reporting requirements
Develop and maintain audit programs for clinical trial safety activities, CRO and other external partners
Plan and conduct PV audits of pharmacovigilance vendor, internal processes, systems, and documentation to ensure compliance with SOPs and regulatory requirements
Oversee validation and ongoing compliance of the electronic adverse event database used for tracking, storing and reporting serious adverse events
Establish quality review processes for adverse event reports (internal and external), expedited safety reports, clinical study report safety sections, and regulatory submissions
Partner with the Drug Safety and PV on implementation of quality metrics and KPIs to monitor the performance of adverse event reporting activities.
Review annual safety reports and other safety documentations for quality and compliance
Develop and oversee quality training programs for internal staff and external CROs on GVP/GCP principles, quality standards, and compliance requirements
Partner with the Drug Safety & PV to ensure consistent training on drug safety procedures with quality oversight
Implement risk-based quality management approaches for pharmacovigilance activities
Lead quality improvement initiatives to enhance the efficiency and effectiveness of safety surveillance operations
Monitor industry trends, regulatory updates, and best practices to ensure the PV QMS remains current
Provide GVP QA oversight of the development of all pharmacovigilance SOPs, work instructions and quality records
Manage and maintain the Quality Event and CAPA system for pharmacovigilance, tracking issues from identification through closure
Foster a culture of quality awareness and continuous improvement within the pharmacovigilance function
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Qualifications
Bachelor's degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred
Current and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations
Experience with electronic Quality Management Systems and Trial Master File.
Auditor certifications a plus.
Up to 10% travel may be required.
Experience in hosting or supporting clinical trial or Drug Safety-related regulatory inspections a plus.
Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP/GVP compliance objectives.
Ability to use expertise and skills to contribute and achieve Cytokinetics' company objectives and principles in creative and effective ways.
Other duties as assigned.
#LI-HYBRID
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $206,150 - $227,850 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through non-standard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
As the Associate Director, Good Pharmacovigilance Practice (GVP) Quality Assurance, you are a key member of the Clinical Quality team representing Clinical QA in cross functional setting, and advising Cytokinetics Drug Safety and Pharmacovigilance teams on GVP matters. This role will liaise and interface with internal and external stakeholders to assess and support GVP compliance with local, GVP guidelines and applicable regulations to drive and maintain quality standards and regulatory compliance culture at Cytokinetics. The ideal candidate has a quality mindset in global clinical development and oversees quality activities including but not limited to representing QA on clinical study teams, inspection readiness, internal and external audits with a proven ability to manage multiple complex projects. You will lead, execute and manage GVP QA activities while being an advocate to driving quality and regulatory compliance culture at Cytokinetics.
This is an excellent opportunity to help enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of Cytokinetics growth!
Responsibilities
Responsibilities include QA Lead to ensure Good Pharmacovigilance Practice (GVP) compliance and the quality of all deliverables including:
Develop, implement, and maintain the Pharmacovigilance Quality Management System (PV QMS) ensuring alignment with global regulatory requirements (ICH, FDA, EMA, etc.)
Establish and oversee quality standards, processes, and procedures for all safety surveillance activities related to investigational drugs
Ensure the PV QMS supports corporate compliance with domestic and international adverse event reporting requirements
Develop and maintain audit programs for clinical trial safety activities, CRO and other external partners
Plan and conduct PV audits of pharmacovigilance vendor, internal processes, systems, and documentation to ensure compliance with SOPs and regulatory requirements
Oversee validation and ongoing compliance of the electronic adverse event database used for tracking, storing and reporting serious adverse events
Establish quality review processes for adverse event reports (internal and external), expedited safety reports, clinical study report safety sections, and regulatory submissions
Partner with the Drug Safety and PV on implementation of quality metrics and KPIs to monitor the performance of adverse event reporting activities.
Review annual safety reports and other safety documentations for quality and compliance
Develop and oversee quality training programs for internal staff and external CROs on GVP/GCP principles, quality standards, and compliance requirements
Partner with the Drug Safety & PV to ensure consistent training on drug safety procedures with quality oversight
Implement risk-based quality management approaches for pharmacovigilance activities
Lead quality improvement initiatives to enhance the efficiency and effectiveness of safety surveillance operations
Monitor industry trends, regulatory updates, and best practices to ensure the PV QMS remains current
Provide GVP QA oversight of the development of all pharmacovigilance SOPs, work instructions and quality records
Manage and maintain the Quality Event and CAPA system for pharmacovigilance, tracking issues from identification through closure
Foster a culture of quality awareness and continuous improvement within the pharmacovigilance function
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Qualifications
Bachelor's degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred
Current and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations
Experience with electronic Quality Management Systems and Trial Master File.
Auditor certifications a plus.
Up to 10% travel may be required.
Experience in hosting or supporting clinical trial or Drug Safety-related regulatory inspections a plus.
Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP/GVP compliance objectives.
Ability to use expertise and skills to contribute and achieve Cytokinetics' company objectives and principles in creative and effective ways.
Other duties as assigned.
#LI-HYBRID
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $206,150 - $227,850 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through non-standard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer