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 Associate/Director, GxP Document Control and Training. The position reports to the VP, GxP Quality Assurance. The location of the position is in Brisbane, CA.
The Associate/Director GxP Document Control and Training is responsible for managing the QA GxP Document Control System and GxP Training Program by ensuring compliance to quality objectives and regulatory requirements are met. In addition, the role will support Myovant’s non-GxP training program(s). He or she will develop control procedures, provide training and maintain Myovant QA’s Electronic Document Management System (EDMS) and Learning Management System (LMS).
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 and Responsibilities
- Performs a wide variety of activities to support the GxP QA department and to ensure compliance with applicable quality objectives and regulatory requirements.
- Implements, maintains and improves the Document Control and GXP Training program and processes to ensure compliance with current GXPs.
- Maintains systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems.
- Provides administration and troubleshooting for the EDMS and LMS.
- Provides internal technical support and escalates as appropriate to EDMS/LMS vendors’ technical support.
- Participates in computer system change management and system validation.
- Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
- Manages the document periodic review process.
- Works closely with other functions to assure consistency and implementation of best practices across the EDMS platform.
- Collaborates with Functional Area Heads that appropriate training objectives are set for employees and other individuals.
- Designs, develops and delivers high quality and high impact learning products, programs and services that provide functional, GXP and product knowledge for staff to achieve a high level of performance in their jobs.
- Evaluates the effectiveness of trainings, implementing modifications when necessary, and monitors training compliance for staff.
- Manages the collection and maintenance of QA department metrics.
- Provides support for internal and regulatory audits and inspections as required.
- Keeps abreast of the requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Escalates to manager of any regulatory compliance questions and issues.
- Perform other duties as assigned.
Core Competencies, Knowledge, and Skill Requirements
- Expert knowledge of regulatory requirements pertaining to Document Control and Training in GxP environments; knowledge of computerized systems a plus.
- Working with both manual and electronic systems.
- Ability to read, analyze, and interpret standards, procedures, or governmental regulations/guidance.
- Experience applying risk management principles to decision makings
- Ability to write standard operating procedures, work instructions, reports, etc.
- Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc. Especially PowerPoint and/or other presentation software for the purposes of training
- Thorough understanding of Data Integrity concepts and controls. Demonstrates accuracy and thoroughness. Applies feedback to improve performance. Monitors own work to ensure quality.
- Strong organizational and management skills. Develops quality project plans. Coordinates projects. Communicates changes and progress. Completes projects on time and within budget.
- Track record of effective collaboration, effectiveness in team settings, achievement of goals, and deliverables
- Strong communication skills. Writes clearly and informatively. Effectively presents information and responds to questions.
- Demonstrates good knowledge of QA systems principles, concepts, industry practices, and standards.
- Ability to evaluate processes and drive value added enhancements.
- Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
- Experience interfacing with regulatory authorities to present company methodologies and deliverables during inspections.
- Excellent interpersonal skills and ability to develop strong collaborative internal and external relationships; must be able to positively influence stakeholders in order to achieve results.
- 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.
- Sound critical thinking and ability to assess interdependencies when making decisions
- 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.
- 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
- 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).
- Bachelor’s degree required; advanced degree in a scientific field preferred
- At least 10 years of Quality Assurance experience within biopharmaceutical industry in a GXP environment and 7 years of experience with Document Management and Training.
- Strong working knowledge of FDA regulations (Part 11, 210/211), global regulations (EU Directives, including Annex 11) and ICH guidelines.
- Broad knowledge of risk-based quality systems approaches systems and continuous process improvement principles.
- Proactive in identifying opportunities for continuous improvement along with strong problem-solving skills.
- 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 with audits and regulatory inspection support.
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.
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Equal Employment Opportunity