Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative women’s health and prostate cancer solutions. We are currently seeking a qualified, highly motivated, experienced individual for the position of Associate Director/Director, GCP Quality. The position reports to the Senior Vice President, Regulatory Affairs & Quality Assurance. The location of the position is in Brisbane, CA.
As the leader of Myovant’s Clinical QA function, this individual will serve as a strategic and tactical quality professional in managing compliance related to GCPs, pharmacovigilance and other related activities. The individual will be a critical team member who designs and implements risk-based GCP audit programs and compliance oversight. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
- Establish and lead Myovant’s Clinical QA function while promoting a culture of quality within Myovant.
- Planning, coordination, control, and continuous improvement of processes and systems to assure the quality of clinical studies conducted by Myovant.
- Provides effective oversight of systems within Clinical QA and all cross-functional organizations involved in clinical research activities in collaboration with matrix team members and CRO/vendor partners, as appropriate
- Development and implementation of GCP-related quality systems. Oversee audit plans and activities,
- Actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance.
- Training of company staff
- 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
- Experience in conducting effective audits of investigator sites, documents, Trial Master Files, vendors, and internal processes.
- Perform other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstrates a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Communication & Interpersonal Skills
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Employees across the Roivant companies, visitors
- Bachelor’s degree required; advanced degree in a scientific field preferred
- At least 10 years of experience in clinical Quality Assurance.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice (GCP)
- Experience with all phases of clinical trials
- Strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
- Attention to detail as well as a crisp, clear and concise style in written and oral communications
- Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
- Experience leading inspection-readiness activities resulting in successful FDA inspection
- Ability to travel both domestic and internationally, as needed
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- 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.
Equal Employment Opportunity