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1+ months

Director of Quality Control (Palo Alto, CA)

Kelly Services
Palo Alto, CA 94301
Director of Quality Control, Palo Alto, CA





Seeking a Director of Quality Control to ensure compliance with all Federal and State regulations governing the manufacturing of cell and gene therapy products for Phase I/II clinical trials conducted under Investigational New Drug (IND) applications. The Director will oversee the quality control activities related to process development, manufacturing and release testing of products and novel analytical development and assay testing; will ensure facilities and manufacturing operations are conducted according to current Good Manufacturing Practices (cGMP); will provide training and certification for manufacturing and quality control staff; will control distribution, tracking and archiving of clinical materials and provide validation support for all equipment and processes essential to the production of biotechnical products.





Duties include:


Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s).

Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts.

Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.

Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.

Develop policies and procedures as they relate to academic or program activities.

Implement, evaluate and maintain quality control standards to ensure program success.

Establish, oversee and manage financials and schedule for large programs and/or multiple projects.

Recommend the adoption of emerging technologies and the development of new methods and approaches.

Negotiate with internal departments and external agencies with authority to commit resources and effort.

Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.



* - Other duties may also be assigned





DESIRED QUALIFICATIONS:

PhD and 8+ years of industry (or equivalent) experience in a biologics cGMP compliant work environment.

Record of publication of scientific findings in peer reviewed journals

Experience in Immunology, Oncology, Cell and Gene Therapy desirable; experience in Analytical Development


EDUCATION & EXPERIENCE (REQUIRED):


Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.


KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Experience leading, managing, motivating and developing technical staff.

Experience leading complex scientific, engineering or technical research projects or programs.

Detailed understanding of relevant business and technical knowledge and problem resolution.

Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.

Knowledge of emerging technologies, trends, methodologies, and resource management principles.

Demonstrated ability to work and communicate effectively with others.

Exceptional customer relationship and consensus building skills.

Ability to influence and establish effective working relationships in a diverse environment.

Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.






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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-08-21 Expires: 2020-10-22

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Director of Quality Control (Palo Alto, CA)

Kelly Services
Palo Alto, CA 94301

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