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17 days old

Director of Quality - SoCal Immunotherapy Sponsor

Kelly Services
Orange County, CA
**Overview- Who we are.**


We are making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, we are committed to the delivery of treatments that harness the power of the body s immune system to attack cancer cells. If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City Greater Atlanta , Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.


**What we do.**


**Vision** Pioneering the future of immunotherapy.


**Mission Making** the battle against cancer personal through immunotherapy treatments that extend lives.


**How we do it.** We are a purpose-driven, value-based culture. We put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer. Act with Integrity. Be honest, transparent, and committed to doing what s right in every situation. Build Trust: Building trust takes time. Engage teammates, be candid and transparent. Raise the Bar: Harness continuous improvement, foster innovation and elevate our people. Drive Results. Be accountable and execute we win when everyone performs.


**Job Summary**


This position is responsible and accountable for the execution of all activities associated with the Quality Unit Quality Assurance and Quality Control at either of the Immunotherapy Manufacturing Facilities IMF to ensure patient safety. The role ensures the site, process, product, and personnel are compliant with all applicable regulatory requirements. It is a key partner to all Executive Quality and Operations Leadership to ensure FDA readiness.


This role is a key strategic quality leader and needs substantial experience in GMP operations, regulatory inspections, internal and external audit, and excellent verbal and written communication skills. Additional career experience in contract manufacturing is preferred.


**Responsibilities**


+ Participates in developing company

+ Quality strategic plans and objectives.

+ Maintains compliance and inspection readiness for the Site.

+ Facilitates Quality Improvement activities related to compliance, cost and cycle time

+ Drives risk analysis and develops solutions to a variety of complex problems.

+ Partners with IMF site leaders to deliver efficient and effective

+ Quality function performance at the IMF.

+ Ensure that robust/reliable quality system is in place for both internal on-site manufacturing as well as on-site contract manufacturing.


**Scope**


+ Directs overall operational leadership in planning and management of quality systems and activities, including resource management and vendor management, which includes the following:

+ Corrective and preventive action program

+ Change control Document control Validation program GMP material review and disposition Internal and external quality audits

+ Pre- and post-approval compliance audit preparation GMP training program

+ Clinical and commercial manufacturing

+ Quality engineering optional Supply Quality Management/Compliance optional

+ Implements corporate Quality policies ensuring finished products conform to company standards and satisfy GMP regulations.

+ Oversees project risk analysis and develop solutions to a variety of complex problems.

+ Collaborates with other departments during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones.

+ Participates in steering committees that set general business corporate policy and sponsor corporate programs.

+ Interfaces with external customers and FDA during audits and inspections

+ Mentors and develops department personnel, including supervisory / management staff.

+ Defines framework for department objectives, operation schedule, processes and budgets.

+ Contributes to Quality department strategic management.

+ Independently act on behalf of the Quality department to customers of externally manufactured products (clinical and/or commercial).


**Qualifications:**


+ Bachelors degree in a scientific discipline or equivalent.

+ 10 years related experience in cGMP/FDA regulated industry.

+ 5 years of experience managing supervisory personnel and contributing toward the development of department strategy.

+ Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.

+ Experience in the manufacturing of clinical and commercial products, including contract manufactured products preferred.

+ Experience in developing and making formal presentations to executive management.

+ Experience with department budget planning, management and reconciliation.

+ Experience with ERP systems preferred.

+ 10-15% travel


**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/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 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-03-26 Expires: 2021-05-06

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Director of Quality - SoCal Immunotherapy Sponsor

Kelly Services
Orange County, CA

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