Senior Manager, QA Operations

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage pharmaceutical company focused on rare muscle disorders.

About the Position

Edgewise Therapeutics is seeking a highly-motivated and self-directed Quality professional. In this position, you will work as a member of a small, highly-experienced and innovative team to ensure high quality standards for the safe and reliable production of pharmaceutical products. The ideal candidate will have 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, and the ability to work with staff across multiple disciplines are essential to be successful in this position.

To learn more about or story and company culture, visit us at https://edgewisetx.com

Essential Duties and Job Functions

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

Knowledge and Skills

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

Preferred Skills

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)

Education and Experience

8+ years of experience in a GMP environment with a Bachelor's degree or 6+ years of relevant experience with a Master's degree

Salary Range: $115,000-$175,000, title and salary commensurate with experience

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, and stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.

Edgewise Therapeutics

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Senior Manager, QA Operations