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 Sr Manager/ AD GCP Quality. The position reports to the Director, GCP QA. The location of the position is in the South San Francisco area.
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.
This position will play an essential role in the company’s GCP Quality Assurance program. It will focus on ensuring GCP compliance of Phase I, II and III studies across their preparation and conduct phases, providing support throughout the audits’ process, collaborating on the development and conduct of training programs, and supporting the development, review of SOPs as assigned.
The individual is responsible for ensuring studies are performed in compliance with Myovant procedures and all applicable GCP regulatory requirements and will represent Quality on study management teams to provide first-line support regarding GCP compliance. The incumbent is also responsible for collaborating and supporting the scheduling, preparation, and logistical arrangements for routine and for-cause audits; in addition, the incumbent will: (a) manage the review of audits’ reports and the Audit Observation and Response Tables (AORTs), (b) prompt and facilitate the responses to finalize the open actions to achieve a timely closure, (c) file, as per current best practices, the audits’ documents (e.g.: Audit Visit Confirmation Letters (AVCLs), final audit report, AORT, audit certificate, and responses/memos), as required to close actions.
Essential Duties & Responsibilities
- Ensuring GCP compliance of clinical development activities and initiatives as per applicable quality and regulatory requirements.
- Developing, revising, assisting, or providing input in quality systems’ SOPs, as deemed relevant by cross-functional dependencies.
- Supporting GCP Quality audit activities for assigned studies/projects.
- Participating in budget forecasting, planning and tracking for GCP Quality activities.
- Providing expert GCP Quality advice to Clinical Operations, and/or cross-functionally, on current GCP regulations to assure best Clinical/Quality practices.
- Contributing to process improvement, and reporting significant and/or serious ongoing quality deficiencies to Quality and Regulatory Management.
- Supporting the Inspection Readiness (IR) process and related actions.
- Supporting the development of documentation (e.g., slides presentations, reports) for submission to the Quality Council, and preparing timely meeting minutes to document actions and next steps.
- Developing, coordinating, and conducting targeted training to Clinical Operations (e.g.: on SOPs), investigators/site staff (e.g.: GCP presentations for investigator meetings) and others at Myovant (e.g.: Regulatory Affairs).
- Assisting with oversight and management of consultants, on a per-need basis.
- Assisting with the organization, preparation, coordination, and documentation of regulatory inspections of investigator sites or Clinical Operations sponsor inspections.
- Providing selected inspection support as requested by Senior GCP QA management.
- Supporting other assignments, as directed by Quality/Regulatory Management.
Core Competencies, Knowledge and Skill Requirements
- Current and strong working knowledge of GCPs, including ability to interpret and /implement Code of Federal Regulations, ICH Guidelines, and updated initiatives governing the clinical development process
- Excellent verbal and written communication skills, ability to work well in teams or independently, and able to prioritize work, manage multiple projects while maintaining quality; facilitates and advocates Quality Compliance.
- Ability to deal with ambiguity, creative and pragmatic approach to problem solving and keeping things simple.
- Knowledge of medical and statistical practice/techniques, tools and terminology
- Sensitivity of position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented.
- Auditing experience; international auditing experience is preferred.
- This position may require travel up to approximately 25% of the time.
- Customarily and regularly exercises discretion and independent, sound judgment in the performance of the duties described above.
- 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.
Education and Experience Requirements
Requires a BS in a scientific or health related field with a minimum of 8 years of experience in the Pharmaceutical or Biotechnology Industry, and a minimum of 5 years in GCP Quality, Clinical Operations or the equivalent (an advanced degree is a plus).
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
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