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Form of workVice President, Quality (GxP)
About Edgewise Therapeutics
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:
This newly created position will report directly to the CEO (or other C Suite Officer TBD) and lead the company’s Quality Assurance organization ensuring Edgewise maintains a culture of quality and compliance with all regulatory requirements with a focus on optimizing quality and reducing risk. The successful candidate will be a highly experienced and innovative executive Quality leader who will be responsible for strategy and design of the organization, cross-functional Management, processes and procedures, executive level interactions, quality direct reports, third-party management, and audits and inspections. We are seeking a dynamic and seasoned Quality Professional who can bring strategic expertise, strong leadership skills, commercial compliance experience, while also maintaining a hands-on approach to drive a high-functioning department. The VP, Quality will have end-to-end Quality responsibilities inclusive of leading GMP, GCP, and GLP functions.
This is an opportunity to join a growing BioPharmaceutical company located in Boulder, Colorado. The VP position will play an active role in the company’s ultimate success and grow with the company through a generous stock/long-term incentive program.
Essential Job Duties and Functions:
Vice-President, Quality (GxP) Responsibilities: Challenges, Expectations and Deliverables for this position:
- Responsible for directing, coordinating, creating, and evaluating the activities of the Quality Department across Drug Manufacturing (GMP), Clinical Research & Development (GCP), and Pharmacology & Toxicology (GLP) functional activities.
- Development, implementation, and monitoring of of a Quality Management System framework to ensure that Drug Development activities are in compliance with Corporate Policies, US Food and Drug Administration regulations, and other applicable worldwide regulatory requirements.
- Monitoring of external regulatory environment and providing recommendations, as appropriate, to senior management on strategic compliance issues that may impact the company.
- Select, lead and direct Quality staff and consultants.
- Create, review and/or approve all relevant documentation including SOPs, policies, investigation reports, audit reports, Quality Manuals, Quality Systems, etc.
- Ensures a robust and risk-based vendor qualification and audit program is successfully realized throughout our vendor network.
- Provide strategic oversight of internal audits, clinical investigator site audits, vendor audits & qualifications, and corrective/preventative actions to ensure GMP, GLP, and GCP compliance etc.
- Develop and implement departmental budget, timelines, and resources.
- Collaborate with other departments to ensure timely completion of all objectives and milestones, including Drug Manufacturing, Supply Chain, Product Development, Regulatory Affairs, Clinical Research & Development, Pharmacology & Toxicology, etc.
- Develop a risk assessment strategy which aligns with Corporate Risk Management ensuring timely, effective, consistent execution of risk strategy, and including mitigation of risk.
- Oversee and provide strong leadership for reporting of issues/deviations/complaints/risks/trends/ . and ensure they are appropriately communicated to senior leadership.
- Identify process improvement opportunities and ensure they are appropriately implemented.
- Ensure that appropriate Quality and Compliance Metrics are in place, are being measured, and consistently tracked.
- Schedule and lead regular Quality Management Reviews on the status of compliance, Quality Metrics, and Quality Standards for facilities, processes, procedures, and practices.
- Establish and maintain GxP training for all applicable staff and consultants.
- Host and Lead Regulatory Inspections, including Pre-Approval, BioResearch Monitoring, Routine GxP Compliance, and For-Cause, and ensure implementation of inspection-readiness activities.
- Accountable for leadership, strategic oversight and expert input on all quality and compliance issues that arise and ensure corrective/preventative action plans are defined, implemented and effective.
Required Education, Experience and Skills:
Education/Experience Requirements
- Bachelor’s degree or advanced degree (preferred) in a scientific field
- Minimum of 15+ years quality experience in a biotech/pharma environment with at least 5-7 years as the functional head of quality
- Experience in late-stage and commercial stage companies
- Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and or guidance documents
- Experience in leading and managing regulatory inspections for commercial manufacturing licensure.
- Excellent, current knowledge of GMP/GCP principles
- Excellent understanding and experience working with multiple dosage manufacturing and packaging
- Excellent hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
- Established leader in the pharmaceutical industry with clear and proven capability developing, coaching, communicating, leading, managing and inspiring within and beyond Quality organizations and efforts
Special knowledge or skills desired and/or licenses or certificates
- Advanced degree (MS, PhD, MBA)
- Certified Quality Auditor (CQA) or equivalent certification
- Extremely detail-oriented with strong organizational skills and high quality standards
- Highly skilled in technical writing, document editing, management and computerized systems
- Demonstrated ability to make sound, compliant judgements and decisions. Decision making is timely, practical, clear and open.
- Exceptionally strong team leader with excellent interpersonal and communication skills with employees, functional area and executive management, suppliers, vendors and business partners.
- Demonstrated ability to motivate and manage multiple levels of personnel. Skilled at identifying and developing personnel.
- Sets high standards of performance for self and others; assumes responsibility and accountability for completion of assignments or tasks.
- Previous experience in other functional areas (R&D, Quality Control, Operations), in addition to QA experience is a plus
- Multidiscipline expertise and experience in GVP (Good Pharmacovigilance Practices) as well as familiarity with non-Clinical GLP requirements and responsibilities would be a plus.
Travel, Physical Demands and Work Environment
- Some travel required
- Standing or sitting for long periods of time may be necessary
- Office based position
Salary range: $260,000-$360,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, 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.
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, 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.
