Director – Quality Control Operations - San Diego, CA | Biospace
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Director – Quality Control Operations

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
9/13/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Operations, QA, QC, Quality, Quality Control,

Job Description

Let’s Make Things Happen!



Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.



Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.



Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.



Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.



Althea is currently seeking a Director – Quality Control Operations to develop and maintain the analytical and quality control laboratory infrastructure, including statistical support of test methods, sample management and all laboratory electronic systems (e.g. LIMS). This position is expected to work in a highly collaborative, matrix management environment, and provide expert knowledge to develop, implement, and maintain quality operational systems and activities.  



Responsibilities:
•Establishes and directs laboratory infrastructure group in support of testing/release activities for GMP manufacturing. Support may include statistical analysis, sample management, and electronic systems management.
•Identify and sponsor operational excellence and continuous improvement projects in collaboration with the Operational Excellence department aimed at reducing cycle times in GMP labs.  
•Provide leadership of management of laboratory electronic systems in the generation of all batch release data, final substance/product disposition, certificate of analysis generation and stability report trend analysis.
•Responsible for managing the current ‘paperless lab’ initiative to replace all current QC labs paper-based records with electronic methods for data capture, electronic review and approval. Oversee management of all laboratory systems including laboratory information management system, scientific data management system, chromatography data system, electronic lab notebook and all other scientific software used to generate electronic records.
•Design and implement a process for tracking and bringing to closure quality laboratory incidents including, but not limited to Deviations, Corrective/Preventive Actions, OOS, and Internal/External Audit Observations.
•Design and implement a process for setting up and maintaining a QC Services laboratory.
•Provide statistical support to other quality leaders for development of meaningful and measurable departmental key performance indicators (KPI) and collaborate with them to analyze the data for opportunities to optimize department performance.
•Collaborate cross-functionally to implement practical solutions and control systems to ensure the highest level of product quality.
•Oversee process for generation of analytical laboratory services quotes for the client services group including pricing for method development, qualification, validation, in-process testing, release testing, stability testing, product characterization, and 3rd party contract testing laboratory testing.
•Build effective partnerships with department heads to help drive the business toward achieving company objectives.
•Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
•Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Leadership Responsibilities:  
•Engages employees by creating a climate in which they want to do their best.
•Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance development planning.
•Coaches, mentors and develops staff, including overseeing new employee onboarding and providing career development planning and training opportunities.
•Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication
•Manages for results by setting and communicating goals and metrics.
•Identifies recruits and retains top-notch talent.

Requirements

Requirements:
•Bachelor’s degree in a Life Sciences discipline or equivalent required.  A graduate degree (Masters or PhD) in a Life Science or Engineering discipline preferred.  
•Minimum of ten (10) years relevant experience in Quality Control. Experience in multi-client, multi-product CDMO services preferred.
•Minimum of five (5) years of leadership/supervisory experience.
•Strong knowledge of cGMP regulations, especially related to software lifecycle management of laboratory record electronic systems is required. Includes previous experience with LIMS, CDS, and other enterprise and local level laboratory electronic data capture systems.
•Proven track record and established leadership in a GMP setting as it relates to major responsibilities is preferred.
•Demonstrated ability to influence and manage peers in a matrix environment, as well as motivate and mentor personnel and encourage teamwork.
•Detail oriented and strong written and verbal communication skills.
•Advanced knowledge of Microsoft Office applications.
•Knowledge and previous use of JMP statistical analysis software is preferred

If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the Careers section.  Please be sure to note where you saw our ad posting.



We are an EOE dedicated to a diverse work force and Drug Free work environment.

Qualified M/F/D/V candidates are encouraged to apply.