CenterWatch

1+ months

Quality Assurance Manager (Cell & Gene Medicine)

Kelly Services
Palo Alto, CA 94301
**Title:** Quality Assurance Manager



**Position Type:** Direct Hire



**Location:** Palo Alto, CA



**Salary:** $142,000/yr






**Summary:**



Our client is seeking a Quality Assurance Manager (Clinical Manufacturing Quality Assurance Analyst 3) to direct and oversee quality system processes and procedures including, but not limited to Validation Master Plan, Audit Program, Document Management, Deviations, CAPA, and Change Control, and to provide quality assurance oversight of the Quality Systems function for the Laboratory for Cell and Gene Medicine (LCGM).






**Duties:**



Provide technical expertise to direct quality compliance between process development, manufacturing, and regulatory affairs for the LCGM.



Provide leadership and represents Quality Assurance on cross-functional project teams evaluating new quality processes or systems for Phase I/II GMP operations.



Provide leadership and oversight for continuous process improvement as new issues are detected, new knowledge becomes available, or change in regulation that add greater reliability, compliance, efficiency, and drive change.



Direct and oversee inspection readiness activities and investigations to resolve quality issues. Provide technical and quality assessment expertise to support discrepancy resolution and investigations.



Manage evaluation and approval of quality system documentation including but not limited to deviations, change control reports, and document changes for compliance requirements (SOPs, specifications, test methods, etc.).



Provide technical expertise and creativity in defining course of actions related to new processes, deviations, and investigations that may impact multiple functions in the organization.



Technical lead and project manager on process audits of vendors, contract manufacturers, contract laboratories, and quality systems for cGMP compliance to confirm all compliance standards are being met. Results of audits may require modification of process, updating procedures, or other corrective actions.



May manage two or more quality assurance staff in the day-to-day operations for functional area(s) of responsibility. Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees. Ensure work completion within schedule and constraints. Translate strategy to provide direction to own area.



* Other duties may also be assigned






**EDUCATION & EXPERIENCE (REQUIRED):**



Bachelors degree and eight years experience or Advanced degree and five years relevant experience.






**KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):**



Advanced experience applying multidisciplinary scientific principles and practices to provide technical leadership and influence experimental design and coordinate laboratory activity



Extensive experience with Quality Assurance systems and processes.



Expert knowledge and technical understanding of the manufacture of Cellular Therapeutics and testing.



Extensive experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)



Full knowledge of GMP/ ISO compliance and quality systems.



Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups



Experience leading and/or managing technical professionals.



Experience providing technical leadership on complex projects, including developing processes and procedures.



Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro),



Demonstrated resolution of complex issues in creative and effective ways



Proven ability to work under tight deadlines and pressure in a composed manner



Ability to communicate effectively, both verbally and in writing. Ability to influence and advocate course of action of research project.



Works effectively by encouraging collaboration and building productive partnerships across departments



Demonstrates thorough grasp of operational issues and performance standards for own area including key performance metrics






**PHYSICAL REQUIREMENTS:**



Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.



* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job.






**WORKING CONDITIONS:**



Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.



May require working in close proximity to blood borne pathogens.



May at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.



May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights



May require extended or unusual work hours based on research requirements and business needs.







**Why Kelly** **** **?**






With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.



You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.






**About Kelly** ****






At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-09-30 Expires: 2019-12-19

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Quality Assurance Manager (Cell & Gene Medicine)

Kelly Services
Palo Alto, CA 94301

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