Kelly Services VP, Quality Assurance in Menlo Park, California
Kelly Services is actively recruiting for a Direct Hire opportunity in Menlo Park , CA for an VP, Quality Assurance .
Reporting to the Senior Vice President of Technical Operations, the Vice President of QA/QC will lead, direct, and develop the Quality organization. This position will provide strategic guidance to senior leadership in the development, adoption, communication, and training of all employees and external contractors/vendors regarding corporate GxP quality practices, standards, and setting the expectation of compliance by following strict quality standards throughout clinical product development and production. The role will serve as a subject matter expert and resource to corporate functions for interpretation of FDA and regulatory agency regulations and guidelines, as well as corporate standards and policies related to GxPs.
• Guides and supports senior leadership in identifying a quality strategy and developing supporting policies.
• Provides systems support and quality operations to ensure compliant drug development and manufacturing, regulatory communications, and clinical and ultimately commercial distribution.
• Establishes a foundation of quality in all GxP operations, in support of manufacturing, clinical development, pharmacovigilance and regulatory affairs.
• Ensures consistent application of quality standards through the development of Standard Operating Procedures (SOPs), with the preparation and maintenance of the SOPs overseen by the Quality organization.
• Plans and conducts/coordinates GxP (GCP, GLP, GMP) audits, to ensure inspection readiness both internally and at vendors, in accordance with established timelines and within budget, as necessary.
• Plans, schedules, prepares for, conducts, reports, and closes out all audits undertaken. This may include, but is not limited to, audits of clinical study documents (protocols, amendments, informed consent, clinical study reports, advertisements), Project set-up, Project In-Life, Investigator Sites, databases, study reports and sub-contractors.
• Assures that Quality is present in all manufacturing validation and all regulatory documentation.
• Serves as a liaison with the FDA and regulatory agencies.
• Oversees and manages all quality and compliance issues, ensuring appropriate CAPA (corrective and preventive action) plans are defined and implemented.
• Advises senior leadership and functional management regarding quality compliance issues, assessing risk and determining actions necessary to resolve issues.
• Must have biologics, oncology, cell therapy background
• Bachelor of Science (B.S.) degree or equivalent in experience.
• 15-20 years of quality or technical experience within the pharmaceutical or biotechnology industry
• Demonstrated success as a Quality organizational leader, with the ability to lead, direct and develop members and build a Quality organization.
• Experience in a smaller pharma/biotech which has reached commercial stage is ideal.
• Demonstrated success in evaluating quality compliance issues in all phases of clinical development, followed by a recommendation for effectively resolving the business challenge.
• Direct experience and a positive record of performance when presented with a health authority inspection.
• Extensive knowledge of the pharmaceutical research and development process, specifically clinical development, regulatory, and drug submission requirements.
• Broad knowledge of and experience applying compliance regulations.
• Familiar with quality management systems and document control systems, including database creation, utilization, and maintenance.
• Previous experience in establishing GxP (Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)) quality guidelines and FDA regulations compliance.
• Able to respond to inquiries or complaints from regulatory agencies.
• Ability to read, analyze and interpret scientific information and reports, technical journals and legal documents.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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