Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Director, GCP Quality Assurance. The position reports to the Vice President, GxP Quality and Compliance. The location of the position is in Brisbane, CA.
As a leader in Myovant’s QA function, the Senior Director, GCP Quality Assurance will serve as a strategic and tactical professional in the independent assessment, development, implementation, oversight and management of quality and compliance to ensure clinical studies, non-clinical studies and pharmacovigilance related Quality activities are conducted in accordance with applicable regulations and Good Clinical Practices (GCPs). The individual will partner with senior management and stakeholders to define an overarching quality strategy, systems and culture appropriate for Myovant's scope of business.
The Senior Director of GCP QA is accountable for ensuring that sites and vendors are compliant with global regulations, prepared for potential Sponsor and Regulatory Inspections and that the appropriate risk-based processes, systems and activities are in place and performed effectively to protect patient safety, product quality, and data integrity. She/he oversees and plans the scope of departmental responsibilities for external auditing functions by tracking all Clinical Development projects, estimating QA headcount requirements, and interacting with Clinical Development project teams and committees. She/he is also responsible for conducting quarterly management trend analysis reports and providing real time reviews of the status of Quality to senior management.
She/he provides support and oversight of the overall compliance and inspection readiness activities, including internal and external support to investigator sites and Clinical Service providers to prepare for and manage global Health Authority inspections. The Senior Director of GCP QA also plans and conducts internal document audits including selected CSRs, and sections of NDA documents to be filed. Activities also include Pre-Approval Inspection preparations, internal audits, inspection trend development. The individual will work independently and as an effective and engaged team member in a fast-paced environment. They will exercise strong initiative and follow through to achieve target quality objectives. They will maintain confidentiality and will operate in this role with the highest of ethical standards and professionalism.
Essential Duties and Responsibilities
- Provide leadership and guidance to the group that provides QA oversight of GCP, GLP, and PV activities at Myovant and its investigator sites and contract research organizations for clinical and nonclinical studies and PV vendors.
- Manage Quality staff including recruitment, performance management, hiring, staff training and development
- Develop and implement risk-based Quality strategies including establishment and maintenance of phase appropriate quality systems; proactively identify and mitigate quality risks.
- Be responsible for Clinical and Nonclinical quality-related activities and requirements to enable the quality management system; planning and conducting vendor, internal, and site audits; supporting teams during health authority inspections; and providing guidance on quality issues.
- Oversee the external audit program including the development of audit plans and organization of audit priorities and schedules. Responsible for selection and approval of all QA audits, including investigator sites, clinical laboratories, and other Clinical Service Providers (CSPs).
- Perform selected audits, oversight the completion of final audit reports including audit observation and response tables with appropriate internal and external distribution, maintain audit tracking systems, and files, follow-up and satisfactory closure of audit findings for all phases of Clinical Development studies.
- Ensure the conduct of QA due diligence assessments of potential new CSPs and support in the remediation of due diligence and qualification audit gaps.
- In collaboration with function heads, ensure GCP/GLP/PV vendors comply with the applicable quality program and regulations/ guidelines and are prepared for Regulatory inspections.
- Ensure pre-approval and routine Regulatory inspection readiness to prepare for audits by global Regulatory Health Authorities. Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections internally and at clinical sites and CSPs, including follow-up efforts, to ensure successful outcomes and responses to any observations.
- Ensure development, implementation, and maintenance of Quality Systems and SOPs related to GCP/GLP/PV activities.
- Lead Quality incident investigations, including input and approval of plans for resolution of product-impacting Quality issues.
- Partner with external and internal stakeholders to ensure Corrective and Preventative Action Plans (CAPAs) to address findings from incident investigations, audits or Health Authority Inspections are appropriate and effective. Ensure CAPAs are executed, managed and closed in accordance with an in-depth analysis and standard operating procedures.
- Provide quality input and oversight for nonclinical assay validation and review of GLP nonclinical study reports.
- Collaborate with Clinical Operations, Clinical Development, Medical Affairs, Nonclinical, and Safety Management colleagues and the Sr. Director/Head, Quality Systems and Compliance to establish metrics and report the state of GCP/GLP/PV Quality and compliance to senior management. Maintain, monitor and analyze compliance metrics from audits, inspections and CAPAs to identify, investigate, and resolve any trends before they have a significant impact on clinical study data quality and to achieve sustained improvement for quality and compliance activities while championing the highest standards of compliance.
- Ensure Myovant and GCP/GLP/PV vendor activities are compliant with FDA, ICH, EMA regulations and guidelines and industry standards.
- Stay abreast of industry developments, including new regulations, guidance, best practices and ensure training and mentoring staff on global GCP/GLP/PV regulations and guidance.
- Key member of Quality Council and ensure publishing of meeting minutes, adequate documentation, for the implementation and follow ups of key decisions
- Ensure a timely and effective communication and escalation of critical Quality issues to senior management
- Provide GCP QA support to IT initiatives/projects
- Maintain current knowledge and full understanding of compliance and regulatory requirements (FDA, EMA, MHRA, etc.) related to GCP Quality and compliance, and provide leadership and technical direction on application and implementation of these requirements
- Support Myovant's training and document control programs for GCP/GLP/PV related activities. Plan and ensure the execution of all training activities for customers including ongoing assessments of needs, and the effective development and delivery of training programs.
- Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines
- Successfully aligns department/function in support of senior management decisions and policies and fosters creativity and entrepreneurial spirit within the department, function, and company.
- Foster a positive and supportive culture where transparency, appropriate sense of urgency, delivering results, innovative ideas and approach, integrity and personal accountability are valued and a coaching environment in which individuals and teams can excel and continuously grow
- Participate in planning and execution processes for budgets, agreements, and timely processing of payments for invoices ensuring timely, effective use of GCP QA cost center resources
- Undertake projects as directed by VP Quality & Compliance.
- Drive a culture of excellence and motivate employees and consultants to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals.
Core Competencies, Knowledge, and Skill Requirements
- Strong understanding of GCP, GLP, and PV Quality for pre-clinical, clinical, & commercial stage work.
- Thorough understanding of drug development process and the pharmaceutical industry
- Expert knowledge of GCP, FDA, and EU guidelines and regulations with a proven track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.
- Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently.
- Experienced and fully capable to implement and ensure quality in a GCP-regulated environment (eg, GCP oversight, auditing, electronic systems management, laboratory management, PAI inspection readiness)
- Excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction with a positive, ‘can do’ attitude. Persistent but polite in proactively driving change, and able to deal with a diverse group of people with different strengths, skills, and methods of interacting with others while gaining their support. Ability to be productive and focused.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks
- Excellent attention to detail, time management and investigative skills as well as ability to multi-task and shift priorities quickly while working under tight deadlines.
- Deals effectively with pressure; remains flexible, proactive, resourceful and efficient, even under adversity. Highly diplomatic, interactive and tactful role model with exceptional critical reasoning skills. Able to prioritize work for her/himself and/or others and be able to delegate responsibility while maintaining quality. Maintains morale, productivity and focus of group.
- Skilled in developing collaborative internal and external relationships
- Team player willing to roll up her/his sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically
- Ability to make rationale, scientific, timely, and compliant risk-based decisions
- Demonstrated leadership excellence and skills in delegating, influencing and in managing budgets, resources, and priorities; Proven ability to motivate and lead people in a complex, changing environment. Exceptionally strong management, problem solving and negotiating skills are required.
- Unwavering integrity and honesty with a quality mindset and a passion for excellence.
- Ability to monitor processes and products to identify opportunities for continuous improvement.
- Excellent verbal and written communication skills
- Ability to build and manage a high performing group; attract, retain and coach best talent. Develops direct reports in their career paths, particularly ensuring that a successor is evolved.
- Ability to think creatively, take a broad systemic view while maintaining a meticulous eye for detail round out the description of the intellectual skills required for this position.
- Bachelor’s degree required, advanced degree preferred, in science or RN or PA
- A minimum of 15 years of experience preferably in more than one pharmaceutical or biotechnology company with >10 years in an international quality leadership role, or equivalent with increasing responsibility and track record of successful management.
- Project Management and Clinical Operations skills with experience in one or both, including developing and writing SOPs, are also essential as are extensive applied knowledge of both FDA and ICH Guidelines for GCPs.
- A working knowledge of GVP and GLP regulations.
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- Business travel to be ~25% as required
- Ability to operate standard office equipment (familiarity with computer programs such as Excel, Word, Microsoft Project, photocopy machine, etc.) and a working knowledge of database software and computerized systems validation is also necessary
- Ability to work on a computer for extended periods of time.
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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Equal Employment Opportunity