- Administer processes within the QMS including Change Control, Deviations, Product Quality Complaints, CAPA, Escalations, Gap Assessments, and Risk Management for clinical and commercial products. This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations.
- Manage the GxP Change Control Program and work with cross-functional teams to ensure timely initiation, evaluation, review/approval, implementation, and closure.
- Host the Change Control Review Board meetings, generate meeting minutes, follow up on action items, and facilitate resolution when required.
- Lead the handling of Product Quality Complaints (PQC) including triage, partnering with internal and external stakeholders for investigations and timely closures.
- Responsible for Complaint Trending, Deviation/CAPA/EC monitoring, and timely closure.
- Compilation of quality metrics for monthly trending, management review meetings, and follow-up for the closure of action items.
- Update SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
- Assist in inspection readiness activities and plays a key role during inspections/audits.
- Provide support during internal Audits, FDA Audits and Third-party consultant Audits.
- BS degree in Chemistry, Life Science or related discipline and a minimum of 5-7 years of relevant Quality Assurance experience; advanced degree and a minimum of 3-5 years relevant experience required.
- Direct experience with managing Change Control, Deviations/CAPAs, and product quality Complaints systems for clinical & commercial products.
- Full understanding of cGMPs, GLPs and GCPs regulation for pharmaceutical products.
- Familiarity of pharmaceutical product manufacturing processes and analytical laboratory practices.
- Direct experience with GxP electronic systems such as Veeva QualitySuites, MasterControl, etc.
- Demonstrate ability to manage projects and variable workloads.
- Must have excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Direct experience with supporting regulatory body inspections.
- Performing internal & external QA audits.
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Senior Quality Assurance - Redwood City, United States - Revolution Medicines, Inc.
Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies.
As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Revolution Medicines is seeking a motivated individual with a pharmaceutical quality assurance background to play a critical role as the Senior QA Compliance Specialist to manage QMS processes within the Quality Assurance function.
This position will be responsible to administer processes within the QMS including Change Control, Deviations, Product Quality Complaints, CAPA, Escalations, Gap Assessments, and Risk Management for clinical and commercial products.
This role is an individual contributor, reporting into Senior Manager, Compliance.Responsibilities:
Required Skills, Experience and Education:
Preferred Skills, Experience and Education:
An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics.
Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone.
We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy.
For additional information, please contact
