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Synthego
San Francisco Bay Area, | Full Time
$147k-176k (estimate)
1 Week Ago
Associate Director/Director of Quality Assurance
Synthego San Francisco Bay Area,
$147k-176k (estimate)
Full Time | IT Outsourcing & Consulting 1 Week Ago
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Synthego is Hiring an Associate Director/Director of Quality Assurance Near San Francisco Bay Area,

The Associate Director/Director of Quality Assurance, reporting to VP of Quality & Regulatory, will be responsible for Quality Assurance and Validation team to ensure that the Quality management system and all aspects of cGMP are effectively established, implemented, and maintained in accordance with the regulations for manufacturing of guide RNAs for gene therapy applications. This individual, as the head of QA Department, will be responsible for leading and managing QA operations, Quality events, product disposition, and validation activities.

What You'll Do:

  • Provide QA oversight for facility, equipment, manufacturing, testing and release of preclinical and clinical guide RNAs
  • Manage incoming raw materials and product disposition activities
  • Provide direct oversight for major investigations/non-conformance events including out of specification events
  • Provide oversight for commissioning, qualification and validation activities for the facilities, utilities equipment and computerized systems
  • Support audit programs and host customer audits and regulatory inspections
  • Manage all QA-related interactions with customers including timely client notification and compliance to quality agreement terms
  • Work closely with cross-functional teams including Regulatory and Compliance, QC, Manufacturing, Facility, Engineering, and Supply Chain to enforce quality and compliance requirements
  • Lead Quality Management Review and ensure the effectiveness of the Quality Management System by proactive gap assessment and remediation
  • Responsible for trending, reporting, and improving KPI metrics for QA and Validation, including timely closure of quality events and adherence to schedule for product disposition
  • Manage and mentor QA and Validation personnel and oversee their performance management and career development

About You:

  • Minimum Bachelor’s degree with 10 years experience in GMP environment in Life Sciences (advanced degree is preferred and counts as years of experience)
  • Minimum 6 years job experience in Quality, with at least 3 years management experience in Quality Assurance and Validation
  • Working knowledge of ISO 9001, 21 CFR Part 210 and 211, 21 CFR Part 11
  • Excellent planning, prioritizing and project management skills and the ability to apply these skills effectively to ensure timely delivery in a fast pace environment
  • Excellent oral/written communication skills, including facilitation and presentation skills.
  • Excellent interpersonal skills, including leadership, influencing, and relationship-building across functions

Company Perks & Benefits:

  • Equity options
  • Medical, dental, and vision benefits
  • 401k Program
  • Fully stocked kitchen with beverages & snacks
  • Paid parental leave
  • Flexible paid time off

Additional information:

  • The posted compensation range covers Associate Director to Director leveling and will be based on experience.
  • The company does not provide immigration sponsorship for this position.

Job Summary

JOB TYPE

Full Time

INDUSTRY

IT Outsourcing & Consulting

SALARY

$147k-176k (estimate)

POST DATE

07/11/2024

EXPIRATION DATE

08/07/2024

WEBSITE

synthego.com

HEADQUARTERS

MENLO PARK, CA

SIZE

200 - 500

FOUNDED

2010

TYPE

Private

CEO

VANESSA GREEN

REVENUE

$10M - $50M

INDUSTRY

IT Outsourcing & Consulting

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About Synthego

Synthego develops a machine learning-based platform that offers genome engineering solutions for researchers.

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