Senior Director/ Director Clinical Quality Assurance

Location
South San Francisco, CA
Posted
May 25, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

LOCATION: South San Francisco or REMOTE

DIVISION: Product Development                                        DEPARTMENT: Quality Assurance           

REPORTS TO: Chief Development Officer


Day One was founded to address a critical unmet need: children with cancer are being left behind in a cancer drug development revolution. Our name was inspired by the “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. We aim to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One. 


SUMMARY: 

The Director, Clinical Quality Assurance, supports quality assurance and compliance functions by managing, planning, scheduling, overseeing, and conducting GCP Quality Assurance and Compliance activities.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Supports/leads the successful implementation and maintenance of an effective quality and compliance program specific for GCP, taking into account ICH guidelines, US, European, and other countries’ requirements

Supports the Day One organization in:

  • Managing and executing “second line of defense” accountabilities e.g., training and development, support for auditing, investigations, routine assurance reporting, updating procedural documents, etc.)
  • Driving and embedding a culture of ethics and integrity.
  • Hosts/leads/supports regulatory inspections and business partner audits
  • Ensures the company is always prepared for regulatory inspections and audits by the development of tools and training for functional departments
  • Develop and facilitate GCP/GXP training for functional areas and personal involved in the execution of clinical trials
  • Participate in the evaluation, qualification and selection of CROs and other clinical and when relevant nonclinical service providers and support due diligence activities.
  • Serve as an expert and provide guidance on and interpretation of GCP/GCLP/GVP regulations, standards and quality systems
  • Participates in quality activities to set and translate overall quality strategy into programs for implementation
  • Leads/supports QA-initiated audit activities, internal and external, including maintenance of audit forms and toolkits as needed
  • Supports creation of QA audit schedule and suggests internal and external audit targets including vendors, service providers and clinical sites in support of registrational studies
  • Supports in a timely review of Quality Event and CAPA plans identified via the audit and inspection processes
  • Ensures implementation of procedures and other documents to support successful QA hosting of regulatory inspections, including interview preparation and backroom support
  • In collaboration with the GMP QA team, prepares, reviews and delivers presentations regarding GxP Compliance to senior management; initiates or reviews other presentations needed to support quality and compliance activities
  • Presents quality and compliance concerns to Day One Bio management, functional areas, and external customers in a professional, collaborative manner
  • Acts as liaison to Day One Bio functional groups, working collaboratively to address issues related to GCP/GCLP/GVP issues
  • Collaborates with other internal Quality functions (GMP) to align on quality goals, processes and procedures for Day One in preparation for commercial launch and post market.
  • Performs other activities, as assigned, to support overall organization’s goals and objectives 
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    REQUIREMENTS:

  • Knowledge of the overall drug development process is required
  • Strong knowledge of US and international GCP requirement practices, global regulations regarding clinical development, auditing and regulatory inspection is required. Experience with GLP/GCLP/GVP is preferred
  • Adept at problem identification, problem solving and organizational skills is required
  • Ability to work in a dynamic organization with aggressive timelines and multiple deliverables
  • Experience with quality assurance activities in a regulated environment is required
  • Experience with audit reporting and CAPA management is required
  • Experience with conducting investigation, root cause analysis, and CAPAs, specifically in the context of GCP regulatory inspection and audit responses is required
  • Experience in applying organizational policy or procedures to a variety of situations is required
  • Adept in training and implementing procedures compliant with FDA/EMA/ICH/WHO guidance and regulations is required
  • Minimum of 8 years of experience in supporting and conducting clinical quality and compliance activities and vendor audits is required
  • Experience in leading audits and sponsor regulatory inspections is required
  • Experience in drafting responses and implementing corrective and preventive actions to address audit and inspection observations is required
  • Experience in Part 11 computer system validation activity specific to configuration management and UAT is preferred
  • Excellent command of English language verbal and written communication skills
  • Demonstrated skill in supervising quality and compliance personnel and project management
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    EDUCATION/ TRAINING:

     

  • BS or MS degree in Clinical or Scientific discipline preferred
  • Minimum 12 years of pharmaceutical industry experience, with at least 8 years of clinical quality assurance experience
  • Proficient in Microsoft Office applications (e.g., Word, Excel and PowerPoint)
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    JOB COMPLEXITY:

    ·       Works on assigned problems of complex scope with analysis of situation or data required

    ·       Exercises judgment within defined procedures and practices to determine appropriate action

    ·       Builds productive internal and external working relationships

    ·       Uses professional concepts and company’s policies and procedures to solve a variety of routine problems.

     

    DISCLAIMER


    The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.