Director, GCP Quality Operations

DIRECTOR, GCP QUALITY OPERATIONS 

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned.

POSITION SUMMARY:   

The purpose of the Director, GCP Quality Operations is to provide expertise and leadership in the areas of Good Clinical Practice Regulations (GCP) & Pharmacoviligence, global regulations, and industry standard best practices.  The Director, Quality Operations provides assurance of patient safety and data integrity and supports Quality Assurance Leadership 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:  

• Reports to Senior Director, GXP Quality Assurance
• Member, Quality Council
• Partners with other Day One Biopharmaceuticals Quality functional partners to assure consistent professional standards and harmonization
• Works with all relevant local and global Day One Biopharmaceutical staff and business partners 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

Primary Responsibilities

Vendor Compliance

• Represents GCP/GLP/GVP Quality and Compliance interests in the vendor and systems assessment process
• Provides guidance and subject matter expertise to business partners on training, quality and compliance issues. 
• Liaises with  internal/external key stakeholders,  to lead, support, and monitor 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.
• Support the development of process documents and provides quality review and guidance where needed.
• 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 Indicators, implementation, and monitoring and supports identification and development of Key Performance Indicators
• Facilitates quality issue management and assesses adequacy of proposed corrective and preventive actions (CAPAs).
• Monitors trends in quality issues and propose remediation actions.
• Recommends changes to policies and procedures that improve quality and efficiency
• Develop and implement Quality Agreements for 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 vendor’s product or services
• Embraces latest technology to enhance visualizations of quality assurance metrics that facilitate better decision-making
• Performs SOP quality reviews, gap analysis and  conduct continuous improvement assessments of current  SOPs.
• Ensures quality activities are performed and documented in compliance with corporate policies, standards and all applicable global regulations with minimal supervisory oversight.
• Provides support and advice to cross functional teams in preparing for and through participation in inspections.

Quality Management

• Provides project and/or program level 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 in the development and maintenance of risk- based audit plan.
• Supports operational systems and plans for data collection, analysis, and action to achieve continuous improvement.
• Supports 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.
• Fosters compliance in leadership across procedures and processes, employing quality oversight with reference to regulations as required.
• Engage with cross functional team members to  promote  risk management strategies, plans, and processes.
• Supports the organization with inspection readiness and execution efforts .
• 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
• 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 Quality as required

QUALIFICATIONS  

• Bachelor’s degree or equivalent experience in life sciences or quality required; Advanced academic qualification/degree preferred
• Equivalent professional experience will be considered.
• 10+ years of GLP/GCP/GVP quality risk management and/or quality assurance experience
• Demonstrate excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
• Relevant work experience in a PV QA related role for a pharmaceutical company (or equivalent combination of Drug Safety and Quality Assurance experience) strongly preferred
• 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. 

INTERVIEW INTEGRITY 

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone. 

COMPENSATION AND BENEFITS 

The salary range for this position is $200,000 - $215,000. 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.