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Quality Compliance Specialist
851 Harbor Bay Parkway Alameda, CA 94502 US
Job Description
Target PR Range: 34-44/hr
*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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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