Manager / Senior Manager, Quality Assurance (QMS)
Location: South San Francisco, California, United States
The Manager / Senior Manager, Quality Assurance will play an instrumental role in the administration of computerized Quality Management Systems (QMS) including document control, training, deviations, CAPAs, change controls, complaints, recalls, audits, and quality agreements. Additionally, this function will be responsible for QA oversight of validation activities.
Key Responsibilities include:
- Business administration of computerized Quality Management Systems, with emphasis on document control and training systems.
- Ensure QMS workflows progress in a timely fashion; compile and report QMS metrics to senior management.
- Train system users and provide user support
- Review and approve QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls
- Facilitate change control committee meetings
- Ensure QMS is compliant with health authority regulations.
- Identify and drive QMS continuous improvement efforts, including implementation of new computerized systems.
- Provide QA oversight of computer system and process validation efforts. Review and approve validation documentation including master validation plans, specifications / requirements, protocols and test scripts, and summary reports.
- Perform GxP audits of internal departments and external contract service providers.
Preferred Qualifications include:
- BA/BS in scientific discipline
- 10 years relevant experience, preferably in a regulated environment (FDA / EMA, etc.)
- Working knowledge of Code of Federal Regulations (CFR) and International Community for Harmonization (ICH) Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
- Quality computer system administration (Veeva preferred)
- Demonstrated knowledge of computer system validation
- Familiarity with process validation
- Knowledge of pharmaceutical manufacturing and/or laboratory practices, techniques, and terminology
- Experience auditing or working with Contract Manufacturing Organizations
- Excellent oral and written communication skills
- Ability to work independently with minimal supervision
- Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible and constructive manner
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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