Senior Quality Manager
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.
Date Posted
10/28/2023
Views
3
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