Edgewise Therapeutics · 2 days ago
Senior Manager, QA Operations
United States
Full-time
Remote
Senior Level, Lead/Staff
$115K/yr - $175K/yr
8+ years exp
Maximize your interview chancesBiopharmaBiotechnology
Insider Connection @Edgewise Therapeutics
Get 3x more responses when you reach out via email instead of LinkedIn.
Responsibilities
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements in support of clinical and commercial programs
Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met
Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
Reviews manufacturing, and quality control data for in-process and finished products, including master batch records, executed batch records, deviations and change controls
Responsible for final release of manufactured products and labeled clinical supplies for Edgewise.
Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications
May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products
Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products, including laboratory investigations, and may assist in compliance audits as required
Interfaces with contract manufacturers to address and resolve more complex product/process performance issues
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Significant experience in all Quality Assurance and batch disposition activities related to the manufacturing of pharmaceutical products
Strong written and verbal communication skills
Hands-on execution
Ability to work with staff across multiple disciplines
In-depth knowledge of GMPs, pharmaceutical manufacturing, QA principles, and industry standards
Excellent verbal, written, and interpersonal communication skills
Keen understanding of international quality systems regulations, best-in-class systems and processes, and continuous improvement initiatives
Strong understanding of Computer System Validation (CSV) including current electronic records and signature requirements
8+ years of experience in a GMP environment with a Bachelor’s degree or 6+ years of relevant experience with a Master’s degree
Preferred
Experience with Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, & performance and quality improvement statistical measures
Experience with Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA))
Benefits
Health benefits
Discretionary bonus plan
Stock option grants
Stock purchase plan
401(k) with match
Paid time off
Company
Edgewise Therapeutics
Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$538.5MKey Investors
Viking Global Investors
2024-01-19Post Ipo Equity· $240M
2022-09-13Post Ipo Equity· $138M
2021-03-26IPO
Leadership Team
Alan Russell
Co-Founder & Chief Scientific Officer
R.Michael Carruthers
Chief Financial Officer
Recent News
Company data provided by crunchbase
