Director/ Senior Director, GVP Quality Assurance
Soleno, Redwood City, California, United States, 94061
About Soleno Therapeutics Inc
Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.
At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are - it is in our chromosomes - and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.
We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.
Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact-and making history.
We all share the most important goal of bringing solutions to the PWS community.
Summary of Job (brief description)
The Director/Senior Director, GVP Quality Assurance, is responsible for supporting the development, coordination and implementation of Global Pharmacovigilance regulations related to quality assurance activities. This individual will serve as the primary QA inspection lead for pharmacovigilance activities, ensuring that Soleno maintains continuous inspection readiness across PV systems, vendors, and processes/documents at all times.
The Director/Senior Director, GVP Quality Assurance will ensure Good Pharmacovigilance Practice (GVP) within Soleno throughout all phases of the product development life cycle, including post-marketing stages globally.
Responsibilities include execution of internal and external Pharmacovigilance (PV) audit programs, as well as leading and coordinating Pharmacovigilance-focused health authority inspections. In addition, the Director/Senior Director, GVP Quality Assurance will be responsible in monitoring the performance and effectiveness of the pharmacovigilance system and its quality system by providing independent Pharmacovigilance-related oversight of the implementation of Soleno's quality systems: training, deviations, corrective and preventive actions (CAPA), risk management and policies/procedures/work instructions.
Key responsibilities are to perform global PV related audits and provide GVP QA support for the Pharmacovigilance System Master File (PSMF).
Thorough knowledge of PV global regulations and guidelines is required. Experience working in a virtual pharmaceutical environment is highly desired.
Responsibilities
Ensure compliance with global pharmacovigilance regulations, including FDA postmarketing safety requirements, EMA GVP modules, and ICH guidelines Implement and maintain the risk-based internal and external (vendor) PV audit program, including risk strategy, tactical and operational audit planning: Ensure PV audits are scheduled, conducted and reported as planned
Ensure PV audit CAPAs are established, agreed and tracked to closure
Ensure PV audit metrics are prepared, analyzed and improvements instituted
Inspection Readiness: Lead PV inspection readiness activities, including gap analyses, mock inspections, and other inspection preparations as applicable Serve as the QA inspection lead during any FDA, EMA, or other global health authority PV inspections
Coordinate inspection logistics including war-room management, document requests, and responses to inspectors Ensure timely and high-quality resolution of any observations obtained during inspections.
Oversee deviations impacting on PV: Identify and monitor deviations impacting on PV Ensure CAPAs are established Verify effectiveness of the CAPAs
Support periodic and ad-hoc review of PV department policies/procedures/work instructions Support review of quality systems procedures from a PV QA compliance perspective Perform induction and ongoing PV training of Soleno's employees Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations Provide EU QPPV with necessary QA data allowing oversight of the PV quality system Oversight of PV compliance metrics and perform trending, where required Manage the product complaint process, oversight of product complaint compliance metrics and perform trending, where required Respond to general PV-QA queries and provide advice and guidance to PV Operations, QA and other functional groups in relation to PV topics Monitor, analyze and communicate PV regulation, guidance changes Coordinate with GMP QA, GCP QA and Quality Systems QA colleagues ensuring harmonized quality approaches Attend company, departmental and cross-functional meetings as required Report to supervisor on project progress, issues, and problem solving Perform other relevant duties as assigned Qualifications
A degree in a scientific or technical discipline with a graduate degree preferred • 8-10 years GVP experience in Biotech/Pharmaceutical Industry including direct, hands-on experience supporting and/or leading regulatory inspections Experience interacting directly with FDA, EMA, and other global health authorities in the context of PV inspections or other regulatory inquiries Knowledge of quality standards and regulatory guidelines and requirements relating to pharmaceutical and/or biotech products and a strong working knowledge and application of global GVP regulations and guidance Demonstrated skills and experience in the conduct of Quality activities as described above Experience of internal Quality Systems Auditing A highly motivated individual who is organized and methodical with strong project management, analytical, problem-solving and interpersonal skills Good prioritization capability and comfortable adapting to meet changing priorities Excellent interpersonal skills with an ability to communicate quality concepts effectively Excellent collaboration skills to optimize the relationship with internal and external partners Comfortable working in an environment where QMS will expand and grow in support of company growth Ability to travel required. Anticipated travel: 30%
Salary Range:
$235,000 - $280,000
(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the location where this position may be filled.)
Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.
At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are - it is in our chromosomes - and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.
We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.
Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact-and making history.
We all share the most important goal of bringing solutions to the PWS community.
Summary of Job (brief description)
The Director/Senior Director, GVP Quality Assurance, is responsible for supporting the development, coordination and implementation of Global Pharmacovigilance regulations related to quality assurance activities. This individual will serve as the primary QA inspection lead for pharmacovigilance activities, ensuring that Soleno maintains continuous inspection readiness across PV systems, vendors, and processes/documents at all times.
The Director/Senior Director, GVP Quality Assurance will ensure Good Pharmacovigilance Practice (GVP) within Soleno throughout all phases of the product development life cycle, including post-marketing stages globally.
Responsibilities include execution of internal and external Pharmacovigilance (PV) audit programs, as well as leading and coordinating Pharmacovigilance-focused health authority inspections. In addition, the Director/Senior Director, GVP Quality Assurance will be responsible in monitoring the performance and effectiveness of the pharmacovigilance system and its quality system by providing independent Pharmacovigilance-related oversight of the implementation of Soleno's quality systems: training, deviations, corrective and preventive actions (CAPA), risk management and policies/procedures/work instructions.
Key responsibilities are to perform global PV related audits and provide GVP QA support for the Pharmacovigilance System Master File (PSMF).
Thorough knowledge of PV global regulations and guidelines is required. Experience working in a virtual pharmaceutical environment is highly desired.
Responsibilities
Ensure compliance with global pharmacovigilance regulations, including FDA postmarketing safety requirements, EMA GVP modules, and ICH guidelines Implement and maintain the risk-based internal and external (vendor) PV audit program, including risk strategy, tactical and operational audit planning: Ensure PV audits are scheduled, conducted and reported as planned
Ensure PV audit CAPAs are established, agreed and tracked to closure
Ensure PV audit metrics are prepared, analyzed and improvements instituted
Inspection Readiness: Lead PV inspection readiness activities, including gap analyses, mock inspections, and other inspection preparations as applicable Serve as the QA inspection lead during any FDA, EMA, or other global health authority PV inspections
Coordinate inspection logistics including war-room management, document requests, and responses to inspectors Ensure timely and high-quality resolution of any observations obtained during inspections.
Oversee deviations impacting on PV: Identify and monitor deviations impacting on PV Ensure CAPAs are established Verify effectiveness of the CAPAs
Support periodic and ad-hoc review of PV department policies/procedures/work instructions Support review of quality systems procedures from a PV QA compliance perspective Perform induction and ongoing PV training of Soleno's employees Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations Provide EU QPPV with necessary QA data allowing oversight of the PV quality system Oversight of PV compliance metrics and perform trending, where required Manage the product complaint process, oversight of product complaint compliance metrics and perform trending, where required Respond to general PV-QA queries and provide advice and guidance to PV Operations, QA and other functional groups in relation to PV topics Monitor, analyze and communicate PV regulation, guidance changes Coordinate with GMP QA, GCP QA and Quality Systems QA colleagues ensuring harmonized quality approaches Attend company, departmental and cross-functional meetings as required Report to supervisor on project progress, issues, and problem solving Perform other relevant duties as assigned Qualifications
A degree in a scientific or technical discipline with a graduate degree preferred • 8-10 years GVP experience in Biotech/Pharmaceutical Industry including direct, hands-on experience supporting and/or leading regulatory inspections Experience interacting directly with FDA, EMA, and other global health authorities in the context of PV inspections or other regulatory inquiries Knowledge of quality standards and regulatory guidelines and requirements relating to pharmaceutical and/or biotech products and a strong working knowledge and application of global GVP regulations and guidance Demonstrated skills and experience in the conduct of Quality activities as described above Experience of internal Quality Systems Auditing A highly motivated individual who is organized and methodical with strong project management, analytical, problem-solving and interpersonal skills Good prioritization capability and comfortable adapting to meet changing priorities Excellent interpersonal skills with an ability to communicate quality concepts effectively Excellent collaboration skills to optimize the relationship with internal and external partners Comfortable working in an environment where QMS will expand and grow in support of company growth Ability to travel required. Anticipated travel: 30%
Salary Range:
$235,000 - $280,000
(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the location where this position may be filled.)