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Quality Control Senior Manager

Employer
Myovant Sciences
Location
Brisbane, CA
Start date
Sep 29, 2022

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

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 enthusiastic individuals who share our excitement for this mission.

Summary Description

The Quality Control (QC) Senior Manager is responsible for supporting commercial QC activities at contract service providers (CSPs) and Myovant for active pharmaceutical ingredient (API) and drug product. S/he is accountable for release data review, stability data review and trending, driving deviations, change control and corrective/preventive actions. He/she will also provide Quality support for analytical method transfer/method validation activities, by closely working cross functionally with Analytical Chemistry, Formulation and Contract Manufacturing groups within Myovant and with personnel at CSPs and partners.  The individual must have the ability to work independently, make sound scientific and quality decisions, and function as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.

This position is located in Brisbane, CA.

Essential Duties and Responsibilities
  • Review and evaluate raw data generated for analytical release testing at CSPs for compliance and adherence to method requirements and specifications.
  • Prepare Certificates of Analysis for API and drug product.
  • Support commercial stability program, including review and trending of API and drug product stability data and evaluation of data for assignment of retest date and shelf-life.
  • Review analytical methods and stability protocols/reports for API and drug product to ensure documents are compliant for use in commercial testing.
  • Provide quality support for clinical and commercial method validation and method transfer activities as needed.
  • Provide quality 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.
  • 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.
  • Promote collaboration internally and with external partners to ensure all systems, process, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
  • Assist with other QC assignments.

Core Competencies, Knowledge and Skill Requirements

  • Small molecule analytical knowledge of techniques including HPLC, GC, dissolution 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.
  • Demonstrated communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively.
  • Exercise good judgment and make quality decisions 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.
REQUIREMENTS (Education and Experience)
  • Bachelor’s degree in a scientific discipline or related field 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).

The well-being and safety of our employees is our top priority.  Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based).  Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered.  If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

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 careers@myovant.com.

Equal Employment Opportunity

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Company

We aspire to be the leading healthcare company focused on redefining care for women’s health and prostate cancer. Our experienced team brings significant breadth and depth of expertise in drug development, combined with a commitment to develop new treatments for women suffering from uterine fibroids, endometriosis, and infertility, and men suffering from prostate cancer. We strive to improve the lives of millions of people, while building an innovative, dynamic, and collaborative company where employees thrive.

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Find Us
Website
Phone
650-392-0222
Location
2000 Sierra Point Parkway, Suite 900
Brisbane, CA 94005
United States
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