Senior Quality Manager

Epic Bio Peninsula

Company

Epic Bio

Location

Peninsula

Type

Full Time

Job Description

Who Are We?

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. 

We are looking for exceptional team members who want an active role in building a rapidly growing biotech.

Job Summary 

Senior Quality (QA/QC) Manager at Epic Bio plays a critical role in advancement of clinical programs. The incumbent will have a key role with data management, setting up quality systems, creating product specifications and developing and maintaining the training program.   

 

What you will accomplish 

  • Review of QC data for starting materials, process intermediates, drug substances and drug products.  

  • Manage Out of Specification (OOS) investigations and QC related investigation(s)/deviations  

  • Prepare Epic Bio Certificates of Analysis (C of A) from data received from CMOs or CTLs.  

  • Perform organization and administrative tasks to support developing Quality Systems.  

  • Review and write document (SOPs), provide feedback on the contents, and assess new and revised procedures.  

  • Participate in lean improvement activities involving, compliance, accuracy and efficiency.  

  • Create and maintain Training program at Epic Bio.  

  • Maintain stability programs 

Qualifications 

  • Relevant degree in scientific/related field or equivalent combination of education and experience.  

  • 8-10 years of experience in the biotechnology or pharma industry with a primary focus on quality activities.  

  • Experience of QC methods and regulatory/pharmacopeia requirements.  

  • Working knowledge of ICH guidelines  

  • Working knowledge of Environmental Monitoring procedures and regulatory requirements.  

Technical Requirements and Skills: 

  • Attention to detail and good documentation practices, and proofreading skills with logical stepwise problem solving ability  

  • Well organized with the ability to multitask   

  • Proficiency with MS Office application required  

  • Understand and familiarity with FDA, ICH, European regulatory requirements, guidelines, and recommendations.    

 

Compensation: The salary range for this position is $169,400 to $187,272 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 
 

 

Epic Bio is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.

Epic Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Apply Now

Date Posted

10/28/2023

Views

3

Back to Job Listings ❤️Add To Job List Company Info View Company Reviews
Positive
Subjectivity Score: 0.8

Similar Jobs

Senior Product Manager - Instrumental

Views in the last 30 days - 0

Instrumental is seeking a Senior Product Manager with extensive experience in enterprise SaaS products or deep domain expertise in electronics manufac...

View Details

Senior FP&A Manager (25033-B-840-FIN) - ArsenalBio

Views in the last 30 days - 0

Arsenal Biosciences Inc is a clinicalstage company developing advanced CAR Tcell therapies for solid tumors They are seeking a Senior FPA Manager to w...

View Details

Senior Staff Simulation Engineer - Wisk

Views in the last 30 days - 0

Wisk Aero is seeking a Senior Staff Simulation Engineer to join their Flight Physics Vehicle Modeling FPVM team The role involves designing implementi...

View Details

Senior Simulation Software Integration Engineer - Wisk

Views in the last 30 days - 0

Wisk is seeking a Senior Simulation Software Integration Engineer to lead the integration of highfidelity simulation models develop advanced test fram...

View Details

Engineering Manager - Flow

Views in the last 30 days - 0

Flow is a technologydriven company specializing in multifamily apartment buildings aiming to improve living experiences through innovative solutions T...

View Details

Senior Copywriter, Creative - Wealthfront

Views in the last 30 days - 0

Wealthfront is seeking an experienced Senior Copywriter to join their Creative Team The role involves creating engaging and strategic content to bring...

View Details