TalentCraft
GCP Quality Compliance Specialist/Manager
TalentCraft, Alameda, California, United States, 94501
GCP Quality Compliance Specialist/Manager
Base Pay Range: $40.00/hr - $50.00/hr
The Senior Manager GCP/GVP QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports and conducts audits as requested using a risk‑based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity.
Develops and implements GCP and GVP functional strategy to support cross‑functional deliverables to ensure that quality is embedded within all steps of internal clinical research and operations. Identifies and drives continuous improvement, partnering with Product Development, Clinical Development, Clinical Operations, study and project teams, Medical Affairs, Regulatory, and Global Patient Safety, and other functions as applicable. Aligns key QA strategies with business goals and understands the global regulatory compliance landscape.
Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for internal business stakeholders, represents QA in an outward‑facing and business‑oriented capacity in strategic and decision forums, and triages communication between internal business functions, internally or externally, and QA to provide and ensure delivery on company core goals and pipeline deliverables.
Supervisory Responsibilities No supervisory responsibilities.
Education and Experience
BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 6+ years of related experience
Minimum of 6+ years experience in biotech, pharmaceutical, or related industry or equivalent combination of education/training and experience
Attention to detail, strong investigation, problem‑solving, and organizational skills
Knowledge and experience with GxP processes related to managing vendors, partners, and suppliers
Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards; ISO understanding is a bonus
Administrative experience in organizing and maintaining vendor and audit related records
Proven organizational skills to obtain data across multi‑functional groups and present results in a consolidated and clear manner
Keeps Management informed of status of assigned projects
Knowledge and Skills
Strong written and oral communication skills
Excellent attention to detail and organizational skills
Ability to influence decision makers and utilize sound problem‑solving skills to recommend options and implement effective solutions
Highly skilled at working with ambiguity and complexity, continuously modifying options and solutions across all levels of the organization
Ability to contribute to the development of company objectives and key performance indicators
Strong user of Microsoft Office applications
Working Conditions
Environment: primarily working in an office setting
Essential physical requirements: sitting, standing, and typing
Physical effort/lifting: light – up to 20 pounds
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Research and Quality Assurance
Industries Biotechnology Research and Pharmaceutical Manufacturing
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The Senior Manager GCP/GVP QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports and conducts audits as requested using a risk‑based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity.
Develops and implements GCP and GVP functional strategy to support cross‑functional deliverables to ensure that quality is embedded within all steps of internal clinical research and operations. Identifies and drives continuous improvement, partnering with Product Development, Clinical Development, Clinical Operations, study and project teams, Medical Affairs, Regulatory, and Global Patient Safety, and other functions as applicable. Aligns key QA strategies with business goals and understands the global regulatory compliance landscape.
Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for internal business stakeholders, represents QA in an outward‑facing and business‑oriented capacity in strategic and decision forums, and triages communication between internal business functions, internally or externally, and QA to provide and ensure delivery on company core goals and pipeline deliverables.
Supervisory Responsibilities No supervisory responsibilities.
Education and Experience
BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 6+ years of related experience
Minimum of 6+ years experience in biotech, pharmaceutical, or related industry or equivalent combination of education/training and experience
Attention to detail, strong investigation, problem‑solving, and organizational skills
Knowledge and experience with GxP processes related to managing vendors, partners, and suppliers
Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards; ISO understanding is a bonus
Administrative experience in organizing and maintaining vendor and audit related records
Proven organizational skills to obtain data across multi‑functional groups and present results in a consolidated and clear manner
Keeps Management informed of status of assigned projects
Knowledge and Skills
Strong written and oral communication skills
Excellent attention to detail and organizational skills
Ability to influence decision makers and utilize sound problem‑solving skills to recommend options and implement effective solutions
Highly skilled at working with ambiguity and complexity, continuously modifying options and solutions across all levels of the organization
Ability to contribute to the development of company objectives and key performance indicators
Strong user of Microsoft Office applications
Working Conditions
Environment: primarily working in an office setting
Essential physical requirements: sitting, standing, and typing
Physical effort/lifting: light – up to 20 pounds
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Research and Quality Assurance
Industries Biotechnology Research and Pharmaceutical Manufacturing
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