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Director Of Quality Assurance

In California / United States

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Director Of Quality Assurance   

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JOB TITLE:
Director Of Quality Assurance
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
San Francisco, California / United States

JOB DESCRIPTION :

Essential Functions / Responsibilities:

Key responsibilities include:

 

  • Development of GxP quality strategies for all of Aligos’ development programs to ensure compliance with all applicable regulations
  • Oversight of all GxP quality-related activities
  • Development of standard operating procedures for all GxP functions
  • Development and implementation of quality assurance programs and policies to ensure compliance with all relevant regulations
  • Leading and working closely with project team members to generate quality assurance plans to ensure compliance
  • Coordination of internal and external audits of key GxP activities and related systems
  • Identification of potential program-level quality-related risks and development of mitigation strategies including oversight of GxP service providers
  • Oversight of external quality-related service providers and consultants
  • Development of quality initiatives to address process improvements
  • Ensuring that Aligos is kept current with all new quality-related regulatory requirements
  • Further develop and maintain a quality management system
  • Establishing Quality Agreements with vendor partners
  • Management of all aspects of GMP Quality Assurance functions including review and approval of batch records, release documents for drug substance and drug product, maintain change control records, auditing manufacturers and related GMP activities.

 

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

 

Required Education and Experience:

  • BS/MS Degree with 10+ years of relevant progressive quality affairs management experience in the drug development
  • Demonstrated experience in the biotech/pharmaceutical industry including an ability to operate in a matrixed project team environment including all cross-functional aspects of drug development (e.g., nonclinical, CMC, regulatory, clinical, etc.) to achieve quality goals.
  • Advanced knowledge of GxP quality assurance principles, concepts, industry practices and standards, specifically for GMP
  • High level of oral and written communication proficiency
  • Evidence of strong critical, strategic, and analytical thinking skills
  • Demonstrated record of accomplishment; proven track record of ability to build and manage relationships with business partners
  • Previous experience with building, implementing, and maintaining QA systems and company-wide SOP systems
  • Experience in computer systems validation
  • Demonstrated ability to implement risk management tools   


Preferred Education and Experience:

  • Experience in antiviral and oligonucleotide drug development desired but not essential

 

Additional Eligibility Qualifications/Competencies

 

  • Excellent interpersonal and communications skills, ability to build productive internal/external working relationships with cross-functional teams
  • The successful candidate must be flexible and adaptable to the needs of a small company.


Position Details

May 16, 2021
S1620313884033627
California / United States
San Francisco,
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Director Of Quality Assurance    Apply

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Essential Functions / Responsibilities:

Key responsibilities include:

 

  • Development of GxP quality strategies for all of Aligos’ development programs to ensure compliance with all applicable regulations
  • Oversight of all GxP quality-related activities
  • Development of standard operating procedures for all GxP functions
  • Development and implementation of quality assurance programs and policies to ensure compliance with all relevant regulations
  • Leading and working closely with project team members to generate quality assurance plans to ensure compliance
  • Coordination of internal and external audits of key GxP activities and related systems
  • Identification of potential program-level quality-related risks and development of mitigation strategies including oversight of GxP service providers
  • Oversight of external quality-related service providers and consultants
  • Development of quality initiatives to address process improvements
  • Ensuring that Aligos is kept current with all new quality-related regulatory requirements
  • Further develop and maintain a quality management system
  • Establishing Quality Agreements with vendor partners
  • Management of all aspects of GMP Quality Assurance functions including review and approval of batch records, release documents for drug substance and drug product, maintain change control records, auditing manufacturers and related GMP activities.

 

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

 

Required Education and Experience:

  • BS/MS Degree with 10+ years of relevant progressive quality affairs management experience in the drug development
  • Demonstrated experience in the biotech/pharmaceutical industry including an ability to operate in a matrixed project team environment including all cross-functional aspects of drug development (e.g., nonclinical, CMC, regulatory, clinical, etc.) to achieve quality goals.
  • Advanced knowledge of GxP quality assurance principles, concepts, industry practices and standards, specifically for GMP
  • High level of oral and written communication proficiency
  • Evidence of strong critical, strategic, and analytical thinking skills
  • Demonstrated record of accomplishment; proven track record of ability to build and manage relationships with business partners
  • Previous experience with building, implementing, and maintaining QA systems and company-wide SOP systems
  • Experience in computer systems validation
  • Demonstrated ability to implement risk management tools   


Preferred Education and Experience:

  • Experience in antiviral and oligonucleotide drug development desired but not essential

 

Additional Eligibility Qualifications/Competencies

 

  • Excellent interpersonal and communications skills, ability to build productive internal/external working relationships with cross-functional teams
  • The successful candidate must be flexible and adaptable to the needs of a small company.