Senior Specialist, Quality Systems and Compliance

Company Description

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom.  We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.  

See here for more details on our portfolio.

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here. 

Job Description

The Role:

We are seeking a Senior Specialist, Quality Systems and Compliance to provide quality expertise to support our QS&C team for the development and commercialization of Deciphera’s products in compliance with relevant US, EU and ICH requirements.  The primary responsibilities of this role will be supporting the Quality Systems and Compliance department to ensure GxP compliance.  We are looking for a teammate that can partner with internal departments to support the Document Control (eDMS), Learning Management System (LMS), and Quality Management Systems (QMS), and to implement process improvements to meet business and regulatory requirements.  

This position will report to the Associate Director, Quality Systems and Compliance and can be performed remotely within the US.

What You’ll Do:

• Supports the day-to-day management of the Quality Systems and Compliance department, including the Document Control function.
• Assist with the development and implementation of Quality Systems SOPs, Work Instructions, training materials and reference guides.
• Assists in delivery, maintenance, and continuous improvement of cross-GxP processes in eDMS, LMS, and QMS.
• Generate compliance metrics and prepare routine KPI reports.
• Participate in system validation activities as required.
• Assist in the identification and implementation of continuous improvement opportunities.
• Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Participate in regulatory inspections for our global clinical and commercial programs as needed.

Qualifications

What You’ll Bring:

• 4+ years in Quality Systems/Quality Assurance experience in the life sciences industry.
• Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired.
• Strong software proficiency with Microsoft Suite and other desktop applications, experience using Veeva Vault would be desired.
• Experience developing improvements to electronic Quality Systems.
• Bachelor’s degree in Computer Science, Life Science or related field or applicable experience.
• Ability to manage multiple projects in a dynamic environment.
• A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
• Excellent communication and collaboration skills.
• Must be authorized to work in the US.

Additional Information

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health