We are currently seeking a dynamic, highly motivated, experienced individual for the position of Sr. Quality Assurance Manager. The position reports to the Sr. Director, Quality Assurance. The location of the position is in Brisbane, CA.
The Sr. QA Manager will be responsible for the administration of quality standards and practices within the organization, with routine quality operations oversight of clinical and commercial Contract Service Providers (CSPs) for Drug Substance (DS), Drug Product (DP), and Packaged & Labeled Products.
Essential Duties and Responsibilities
Manage activities for batch record review to support release of DS, DP including but not limited to review of master and executed documents, analytical data, certificates of analysis, and other documents as needed for consistency with applicable regulations and SOPs.
Assess and resolve deviations, product complaints, OOS test results and other quality issues which may arise, in a timely manner, participate in investigations and evaluate proposed CAPAs for feasibility and compliance.
Author change controls and deviations related to QA operations systems.
Provide change control guidance/oversight by working with internal groups and CSPs, assisting with change proposal approval and drafting of implementation plans.
Review and approve Forms, Master Batch Records or other documentation related to manufacture, testing, and release of Myovant Product across all phases of development and commercialization.
Draft or revise written procedures and perform training as applicable.
Support oversight of ongoing vendor performance management including participating in audits as required, supporting business review meetings and escalations.
Proactive in identifying opportunities for continuous improvement along with strong problem-solving skills.
Represent own function and participate in cross-functional project team meetings, Material Review Board meetings, business review meetings and escalations as applicable.
Other projects when assigned
Core Competencies, Knowledge, and Skill Requirements
Ability to work effectively with various technical groups and a strong working knowledge in one or more of the following disciplines: API manufacturing, drug product manufacturing, pharmaceutical sciences, analytical development / QC labs.
Demonstrate working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrate working knowledge of quality assurance systems, methods and procedures.
Demonstrate audit and investigation skills, and report writing skills.
Experience with Fixed Dose Combination or Oligopeptides a plus
Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
Exercise good judgment and make quality decision based on risk management and appropriate for the organization
Results-driven, take initiative and ownership to accomplish work
Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
Strive for continuous improvement and embrace innovative ideas in daily work
B.S. or advanced degree in chemistry, biology, or related science
Minimum of 8+ years’ of direct experience in GMP Quality operations within the pharmaceutical/biopharmaceutical industry
Must have in-depth knowledge of FDA and EU guidelines and have a proven implementation track record.
PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
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.
If you require any accommodations, please email email@example.com.
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.