Quality Compliance Specialist

Target PR Range: 63-71
*Depending on experience

SUMMARY/JOB PURPOSE:
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 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 business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between 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/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
• BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 6 years of related experience

Experience:
• Minimum of 6 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience. • Must have attention to detail and good investigation, problem solving, and organizational skills. • This position requires a 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/Skills:
• Strong written and oral communication skills. • Excellent attention to detail and organizational skills. • Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions. • Highly skilled in the ability to work with ambiguity and complexity and can continuously modify 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:
Facilities/Alameda: • Environment: primarily working in an office setting • Essential physical requirements; sitting, standing, and typing. • Physical effort/lifting; light - up to 20 pounds