Director/ Senior Director, GVP Quality Assurance
Scorpion Therapeutics, Redwood City, California, United States, 94061
Role Summary
The Director/Senior Director, GVP Quality Assurance, leads the development, coordination and implementation of global pharmacovigilance QA activities and ensures GVP compliance across all lifecycle stages. This role serves as the primary QA inspection lead for pharmacovigilance activities, maintaining continuous inspection readiness for PV systems, vendors, and processes. The position ensures Global Pharmacovigilance Practice (GVP) compliance across development and post-marketing activities worldwide. 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%
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The Director/Senior Director, GVP Quality Assurance, leads the development, coordination and implementation of global pharmacovigilance QA activities and ensures GVP compliance across all lifecycle stages. This role serves as the primary QA inspection lead for pharmacovigilance activities, maintaining continuous inspection readiness for PV systems, vendors, and processes. The position ensures Global Pharmacovigilance Practice (GVP) compliance across development and post-marketing activities worldwide. 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%
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