Director GCP Quality Operations Lead

DIRECTOR, GCP QUALITY OPERATIONS LEAD

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

POSITION SUMMARY:

The purpose of the Director, GCP Quality Operations Lead is to provide expertise and leadership in the areas of Good Clinical Practice Regulations (GCP), global regulations, and industry standard best practices. The Director, GCP Quality Operations Lead provides assurance of patient safety and data integrity and supports the Senior Director, GCP Quality Assurance in the execution of the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement.

The scope of this position is global and across partnerships. This position serves as a designated point of contact for dedicated clinical trial projects and/or program teams related to respective clinical quality activities.

This position has the potential to be fully remote. Occasional travel will be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Organizational Relationships

· Reports to Senior Director, GCP Quality Assurance

· Member, Product Development Quality Council

· Partners with other Day One Biopharmaceuticals GMP Quality functional partners to assure consistent professional standards and harmonization

· Works with all relevant local and global Day One Biopharmaceutical staffs as requested

· Works with external contacts including Regulatory authorities (if necessary) as it applies to inspection activities, professional scientific groups, and consultants

· Works with appropriate functional areas to ensure appropriate and proportionate approach to quality and compliance issues and challenges

Primary Responsibilities

Vendor Compliance

· Represents GCP/GLP/GVP Quality and Compliance interests in the GCP vendor and systems assessment process

· Provides guidance and subject matter expertise to business partners on training, quality and GCP compliance issues.

· Collaborate with the Director of GxP Audit Oversight with audit planning and initiates risk- based audit requests as needed.

· Liaises with the Director of GxP Audit and other key stakeholders, internally and externally, to lead, support, and monitor GCP vendor quality issue investigation, root cause analysis, corrective and preventive actions, and effectiveness verification checks through completion, as appropriate when reviewing quality of audit responses.

· Liase with stakeholders to ensure audit response actions are completed in a timely manner and evidence is meets quality requirements.

· Support the development of GCP documents and provide quality review and guidance where needed.

· Support as a member of the study management team and protocol deviation review.

· In partnership with procuring department lead (e.g. Clinical Operations, Pharmacovigilance and Patient Safety or Translational Sciences) and other stakeholders, assesses the need for quality-related Key Quality Indicator, implementation, and monitoring and supports identification and development of Key Performance Indicators

· Ensures quality activities are performed and documented in compliance with corporate policies, standards and all applicable global regulations with minimal supervisory oversight.

· Facilitates GCP quality issue management and assesses adequacy of proposed corrective and preventive actions (CAPA).

· Monitor for trends in GCP quality issues and propose remediation actions.

· Identifies and communicates to senior management the trends impacting clinical quality.

· Recommends changes to policies and procedures that improve quality and efficiency

· Manages development and implementation of Quality Agreements for Day One Biopharmaceuticals GCP vendors; ensures vendor fulfillment of the necessary requirements such as notifications, KPIs, and governance-related activities

· Supports ongoing risk identification, assessment, and mitigation as relates to the GCP vendor’s product or services

· Embraces latest technology to enhance visualizations of quality assurance metrics that facilitate better decision-making

· Manages GCP SOP quality review, identify gaps where a GCP SOP may be needed and conduct continuous improvement assessments of current GCP SOPs.

· Provides support and advice to organization in preparing for and through participation in GCP inspections.

Quality Management

· Provides project and/or program level product development quality support in line with the execution of clinical research and scientific quality processes and compliance requirements, while ensuring patient safety and data and scientific integrity practices are followed and consistent with global policies and procedures.

· Supports the Director GxP Audit and Regulatory Intelligence in the development and maintenance of risk- based audit plan.

· Oversees the completion of resulting CAPAs identified in audit response actions.

· Supports the Senior Director in the definition of operational systems and plans for data collection, analysis, and action to achieve continuous improvement.

· Supports the Senior Director in the leadership of compliance analysis in complex research and scientific situations and supports the provisioning of recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.

· Anchored in commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality proactively.

· In conjunction with the Senior Director and Product Development and Clinical Development Leaders, the Director fosters compliance leadership across procedures and processes, employing quality oversight with reference to regulations as required.

· Shall effectively engage Day One Biopharmaceutical Functional teams, and support functional partner-aligned risk management strategies, plans, and processes.

· Shall support key partners in inspection readiness and inspection execution efforts and developing responses to regulator questions as required.

· Participates in projects outside of current responsibilities as needed to drive the organization forward to success.

· Contributes to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as identified and assigned by the Senior Director, as needed.

· Responsible for clinical and regulatory intelligence knowledge transfer to functional teams and will maintain a current knowledge of industry quality trends as needed.

· Supports risk / impact assessments as needed for regulation updates or possible signals identified in audit metrics and quality issues.

· Assume responsibility for other activities/functions within GCP Quality as required and directed by the Senior Director, GCP Quality.

QUALIFICATIONS

· Bachelor’s degree or equivalent experience in life sciences or quality required; Advanced academic qualification/degree preferred

· Equivalent relevant professional experience will be considered.

· 10+ years R&D experience or relevant experience in science and clinical research, ideally with supporting clinical/regulatory/medical affairs, quality management, translational sciences, clinical development; equivalent experience

· 10+ years of GLP/GCP/GVP quality risk management and/or quality assurance experience

· 5+ years of experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities

· 5 + years’ experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities

· Proven ability to function autonomously in a matrix model and in a team environment

· Proven ability to think creatively and to develop and execute strategic plans

· Travel Required: up to 25%

· Goes beyond the obvious and seeks novel approaches to complex issues

· Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats

· Works seamlessly with other cross-functional departments to include commercial organization and manufacturing organizations

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

COMPENSATION AND BENEFITS

The salary range for this position is $220,000 - $230,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit [https://www.dayonebio.com/benefits> to see our competitive benefits.

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.