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Director, Quality Assurance Operations

Company: Cymabay Therapeutics
Location: Newark
Posted on: June 9, 2021

Job Description:

Position Summary:

Oversee quality operations associated with CymaBay's Clinical Programs and ensuring quality compliance at multiple manufacturing sites. This role is expected to provide leadership for maintaining and enhancing, in a phase-appropriate manner, the quality and compliance culture.

Responsibilities include, but are not limited to, coordinating resolution of quality related issues, review of change controls, QA lot disposition, compilation of trending reports, writing quality investigations and assistance with product complaints investigations to ensure compliance with applicable regulations and regulatory commitments. This includes the quality oversight of contract vendors, and QA lot disposition to ensure on-going compliance with applicable regulations and regulatory commitments. The Director of Quality Assurance Operations may assist with GMP compliance activities by reviewing and evaluating compliance issues/concerns/risks within the organization.

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
  • Manage quality operations team
  • Establish collaborative relationships with internal and external stakeholders to ensure all quality and compliance matters and any issues that arise are addressed in a collabortive and timely manner
  • Complete other responsibilities, as assigned

MINIMUM QUALIFICATIONS

  • Minimum 8-10 years' experience in the pharmaceutical / biopharmaceutical industry and 4 years direct experience in Quality managing CMOs
  • Thorough understanding of GMP regulations and industry practices
  • 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 self-direct and adapt to changing priorities
  • Experienced with regulatory agency interactions
  • Strong attention to detail and excellent organization skills
  • Good verbal, written, and interpersonal communication skills
  • Proficiency in Microsoft Office applications
  • 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

Keywords: Cymabay Therapeutics, Newark , Director, Quality Assurance Operations, Other , Newark, California

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