Director, Quality Assurance & Regulatory Affairs - San Diego, CA | Biospace
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Director, Quality Assurance & Regulatory Affairs

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
11/1/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Director, Manufacturing, QA, Quality Assurance, Regulatory, Regulatory Affairs,

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.

Ajinomoto Althea is currently seeking a Director, Quality Assurance & Regulatory Affairs. This business critical role manages activities to assure compliance with U.S. and international regulatory requirements, including development, implementation, maintenance, and performance of quality assurance systems and programs. The position interfaces with clients as a senior Quality representative.

Responsibilities:

•   Manages quality assurance personnel and projects to assure compliance with client and regulatory requirements.
•   Ensures implementation and maintenance of quality systems including but not limited to SOP writing, batch record review, deviations, technical report review and personnel training.
•   Key liaison between company and clients regarding Quality and Regulatory issues; communicates directly with clients’ senior Quality and/or Regulatory staff.
•   Oversees batch record audits and assures proper batch release documentation.  
•   Assures appropriate reviews and approvals of manufacturing and aseptic filling records for execution as well as for product release.
•   Takes lead role in organizing and completing investigations, coordinates with other departments involved, and drives closure in a timely manner.
•   Manages audits, including audit preparation, execution of the audit, the audit report, and follow up to any finding. Serves as a liaison between the Company and auditors.
•   Provides trend analyses to peers and senior management.
•   Assures that all corrective actions are completed in a timely manner and verifies their implementation.
•   Ensures adherence to cGMP and GLP requirement and SOP’s.
•   Responsible for maintaining internal regulatory submissions and licenses.
•   Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.

Supervisory Responsibilities:

•   Manages exempt and non-exempt Quality and Regulatory staff.
•   Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating and managing performance.
•   Identifies, recruits and retains top-notch talent.

Requirements

Requirements:

•   Bachelor’s degree in a Life Sciences discipline or equivalent.
•   Ten (10) years of relevant experience in a regulated biotech, or pharmaceutical industry in a Quality Assurance function.
•   Minimum of five (5) years of leadership experience.
•   Working knowledge of cGMP’s, FDA regulations (21 CFR Parts 210, 211), ICH Guidelines for Manufacture of API’s and practical experience in auditing practices and procedures.  
•   Working knowledge and understanding of drug development.
•   Detail oriented and strong written and verbal communication skills.
•   Well-developed negotiation skills.
•   Ability to work independently, within prescribed guidelines, or as a team member.
•   Demonstrated ability to dictate detailed directions in a laboratory environment.
•   Must be proficient with Microsoft Office applications.

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.