Director, Quality Assurance Operations

Location
94560, Newark
Posted
Jul 08, 2021
Required Education
Bachelors Degree
Position Type
Full time

CymaBay is a clinical stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases. 

 

If you are ready to join a team where your work is challenging, rewarding and meaningful; where your efforts are recognized and appreciated; where your career and skills are developed and expanded; AND where you are truly VALUED…

then CymaBay is looking for YOU!

 

To help us achieve our mission we are seeking a talented Director, Quality Assurance Operations to join our team. This position will oversee quality operations and ensuring quality compliance at multiple manufacturing sites. This includes the quality oversight of contract vendors, and QA lot disposition to ensure on-going compliance with applicable regulations and regulatory commitments.

 

Essential Duties and Responsibilities

  • Responsible for quality oversight of cGMP activities which include setting up and/or optimizing processes for, drug substance and drug product manufacturing, labeling, batch record review and product disposition
  • Provide direction for complex deviations and other investigations and CAPAs in support of batch release, inspection readiness and regulatory findings including tracking and closure of compliance issues
  • Independently perform and/or manage batch release activities for clinical production including but not limited to review of batch records, analytical data, certificates of analysis, and other documents (e.g., method validation protocols/reports, product specifications, etc.) as needed for consistency with applicable regulations and for compliance with company's GMP Quality System
  • Provide quality assurance leadership, support, guidance and direction to internal manufacturing and quality teams operating under cGMP regulations
  • Provide status reports, including relevant quality metrics and participate in the management review process
  • Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability and efficiency improvement objectives

 

Minimum Qualifications

  • Minimum 8-10 years' experience in the pharmaceutical / biopharmaceutical industry and 4 years direct experience in Quality managing CMOs
  • Expert knowledge of cGMP manufacturing including active pharmaceutical ingredient manufacturing
  • Experience with cGMP manufacturing of clinical trial and commercial products
  • Proven managerial skill and ability to work in a team setting within an organization and with external CMOs
  • Demonstrated knowledge of quality systems that support deviations, CAPA, and change control
  • Experience leading deviation and non-conforming material investigations
  • Ability to effectively lead and participate on multi-disciplinary teams
  • Proven track record of managing and partnering with outside vendors including CMOs and/or CROs
  • Proven technical writing/editing skills and problem-solving ability
  • Ability to operate in a fast-paced, multi-disciplinary virtual environment
  • Ability to travel 20% domestically

 

Education, Certificates, Licenses, Registrations

  • Bachelor of Science degree in scientific field (advanced degree a plus)
  • ASQ Certification a plus