Sr. Director of Quality Control - Vista, CA | Biospace
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Sr. Director of Quality Control

Bachem

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Location:
Vista, CA
Posted Date:
8/3/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Sr. Director of Quality Control is the leader of Quality Control/ Stability laboratory and the Method Transfer/ Validation function.  They are the head of Quality Control for the testing of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial products.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

•   Maintain the Quality Control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics  
•   Develop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validation
•   Ensure continuous improvement and effectiveness of the quality control labs
•   Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements
•   Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees
•   Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
•   Investigate and document out-of-specification results and deviations during product testing
•   Assure and oversee testing and raw materials, ensure safe, secure, and documented storage of final products in GMP manufacturing

Requirements

Required:

•   Master’s Degree in Chemistry or Chemical Engineering with a minimum of 7 years’ work experience in GMP manufacturing or
•   Bachelor’s Degree in Chemistry or Chemical Engineering with a minimum of 10 years’ work experience in GMP manufacturing
•   At least 3 years management experience
•   Knowledge of cGMP and FDA regulations
•   Exhibit detail oriented documentation skills
•   Excellent written and oral communication skills
•   Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
•   Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
•   Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
•   Detail oriented with the ability to troubleshoot and resolve problems
•   Ability to work independently and manage one’s time
•   Communicate effectively and ability to function well in a team environment

Preferred:

•   PhD in Chemistry
•   Experience with Peptides and Oligomer Manufacturing processes