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 redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a dynamic, highly motivated, experienced individual for the position of Sr. QC Manager. The position reports to the Director, Quality Assurance. The location of the position is in Brisbane, CA.
The Quality Control (QC) Senior Manager is responsible for providing oversight of QC activities at contract service providers (CSPs) and Myovant. Primary responsibilities include analytical release data review, stability data review and trending, and driving complex deviation, change control and CAPA activities. He/she will also provide Quality support for technical transfer/method validation activities for Active Pharmaceutical Ingredient (API) and Drug Product as needed, by closely working cross functionally with Analytical Chemistry, Formulation and Contract Manufacturing groups within Myovant and with personnel at CSPs. The individual must have the ability to make sound scientific and quality decisions independently, and function as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Essential Duties & Responsibilities
- Review and evaluate raw data generated for analytical release and stability testing at CSPs for compliance and adherence to method requirements and specifications.
- Review analytical methods and stability protocols/reports for API and Drug Product to ensure documents are compliant for use in commercial testing.
- Collaborate with Quality management to establish commercial QC programs and provide routine oversight of such programs, including stability and reference standards.
- Provide oversight of commercial stability program, ensuring that health authority commitments are fulfilled, and evaluate data for trends.
- Provide quality support for commercial method validation and method transfer activities as needed.
- Independently provide oversight of internal and external quality records including deviations, OOSs, change controls and CAPAs. Assure thorough and compliant investigations are performed with identification of appropriate corrective actions. Proactively collaborate with cross functional teams to ensure timely closure of quality records.
- Review and/or negotiate Quality Agreements.
- Design, author and implement procedures and systems to support commercial Quality Control.
- Track Quality metrics for analytical activities at CSPs and proactively identify and implement improvement opportunities.
- Serve as a Quality representative, participating on cross-functional teams and perform other duties as assigned or required.
- Support Health Authority inspections and CSP audits.
Core Competencies, Knowledge and Skill Requirements
- Small molecule analytical knowledge of techniques including HPLC, GC, and compendial methodologies.
- Strong understanding of Health Authority requirements for analytical method validation and transfer through all phases of development and commercialization.
- Demonstrated quality system expertise, with an emphasis on deviation, CAPA and change control systems.
- 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
- Bachelor’s degree required; advanced degree in a scientific discipline preferred.
- Minimum of 8+ years of progressive experience working in a GMP environment within the biopharmaceutical industry in a quality control role is preferred.
- Prior experience providing oversight of GMP release and stability testing activities at CSPs.
- Strong knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements (FDA Part 11, 210/211, EU Directives, ICH guidelines).
- Experience with audits and regulatory inspections.
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